Company · US
Advanced Sterilization Products
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (1 in 12 months)
69recalls (0 in 12 months)
62recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MLR | Sterilizer, Chemical | 52 |
| FRC | Indicator, Biological Sterilization Process | 23 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 13 |
| FEB | Accessories, Cleaning, For Endoscope | 12 |
| MED | Sterilant, Medical Devices | 9 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 6 |
| FRG | Wrap, Sterilization | 5 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 |
| 688 | 2 | |
| FLE | Sterilizer, Steam | 1 |
| KOG | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 15, 2026 | K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) Advanced Sterilization Products, Inc. | MLR |
| Apr 14, 2025 | K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) Advanced Sterilization Products, Inc. | MLR |
| Jul 5, 2024 | K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOC Advanced Sterilization Products, Inc. | JOJ |
| Jul 5, 2024 | K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Advanced Sterilization Products | MLR |
| May 16, 2022 | K220404 | STERRAD NX with ALLClear Technology Advanced Sterilization Products, Inc. | MLR |
| Oct 9, 2021 | K212174 | STERRAD 100NX Sterilizer with ALLClear Technology Advanced Sterilization Products, Inc. | MLR |
| Jul 31, 2017 | K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Po Advanced Sterilization Products | KCT |
| Feb 16, 2017 | K162007 | STERRAD NX Sterilizer Advanced Sterilization Products | MLR |
| Sep 27, 2016 | K160818 | STERRAD® NX Sterilizer with ALLClear Technology Advanced Sterilization Products | MLR |
| Sep 26, 2016 | K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology Advanced Sterilization Products | MLR |
| Jan 13, 2016 | K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer Advanced Sterilization Products | MLR |
| Oct 29, 2015 | K151971 | STERRAD CYCLESURE 24 Biological Indicator Advanced Sterilization Products | FRC |
| Apr 3, 2015 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer Advanced Sterilization Products | MLR |
| Dec 22, 2014 | K140977 | EVOTECH ECR Advanced Sterilization Products | FEB |
| Dec 19, 2014 | K141693 | Tyvek® Pouch/Roll with STERRAD® Chemical Indicator Advanced Sterilization Products | FRG |
| Mar 28, 2014 | K130263 | STERRAD 50/100S/200 TEST PACK Advanced Sterilization Products | FRC |
| Dec 26, 2012 | K123017 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 Advanced Sterilization Products | FRC |
| Oct 15, 2012 | K112087 | TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS Advanced Sterilization Products | KCT |
| Oct 4, 2012 | K122044 | STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Oct 3, 2012 | K111519 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 Advanced Sterilization Products | JOJ |
| Oct 3, 2012 | K111518 | STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 Advanced Sterilization Products | JOJ |
| Sep 26, 2012 | K111391 | STERRAD (R) 100NX DUO CYCLE TEST PACK Advanced Sterilization Products | FRC |
| Sep 14, 2012 | K111375 | STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Sep 13, 2012 | K111377 | STERRAD(R) 100NX STERILIZER DUO CYCLE Advanced Sterilization Products | MLR |
| Jun 6, 2011 | K103210 | TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS Advanced Sterilization Products | FRG |
| Apr 1, 2011 | K103219 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE Advanced Sterilization Products | JOJ |
| Apr 1, 2011 | K103218 | STERRAD CHEMICAL INDICATOR STRIP Advanced Sterilization Products | JOJ |
| Mar 4, 2011 | K092622 | STERRAD 100NX STERILIZER EXPRESS CYCLE Advanced Sterilization Products | MLR |
| Feb 25, 2011 | K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Feb 25, 2011 | K092755 | STERRAAD 100NX EXPRESS CYCLE TEST PACK Advanced Sterilization Products | FRC |
| Jan 28, 2011 | K102884 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Nov 13, 2008 | K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR Advanced Sterilization Products | FEB |
| Dec 18, 2007 | K071537 | STERRAD 100NX TEST PACK Advanced Sterilization Products | FRC |
| Nov 29, 2007 | K071385 | STERRAD 100NX STERILIZER Advanced Sterilization Products | MLR |
| May 24, 2007 | K071014 | MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Oct 26, 2006 | K061899 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products | FEB |
| Aug 19, 2005 | K051643 | STERRAD STERILIZER CYCLESURE TEST PACK Advanced Sterilization Products | FRC |
| May 12, 2005 | K042450 | STERRAD NX CHALLENGE PACK Advanced Sterilization Products | FRC |
| Apr 22, 2005 | K042116 | STERRAD NX STERILIZER Advanced Sterilization Products | MLR |
| Apr 4, 2005 | K032959 | CIDEX OPA CONCENTRATE Advanced Sterilization Products | MED |
| Mar 15, 2005 | K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products | FEB |
| Apr 2, 2004 | K040742 | MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE Advanced Sterilization Products | JOJ |
| Aug 18, 2003 | K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products | MLR |
| May 2, 2003 | K031226 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Apr 3, 2003 | K023290 | STERRAD 50 & STERRAD 100S STERILIZERS Advanced Sterilization Products | FLF |
| Feb 27, 2003 | K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION Advanced Sterilization Products | MED |
| Oct 8, 2002 | K022441 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE Advanced Sterilization Products | JOJ |
| Aug 28, 2002 | K013003 | APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER Advanced Sterilization Products | FRG |
| Feb 13, 2002 | K994055 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Aug 29, 2000 | K002401 | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) Advanced Sterilization Products | MED |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2017 | Advanced Sterilization Products STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Terminated |
MLR | K042116 K142454 +1 |
| Jan 9, 2017 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004
The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant C Terminated |
FEB | K040883 K061889 +3 |
| Sep 16, 2015 | Advanced Sterilization Products CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. Terminated |
MED | K030004 |
| Aug 25, 2015 | Advanced Sterilization Products CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Terminated |
MED | K060618 |
| Aug 13, 2015 | Advanced Sterilization Products Wall Chart for STERRAD 100NX System, P/N 10104.
The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Terminated |
MLR | K142454 |
| Jun 5, 2015 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002.
The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level di Terminated |
FEB | K140977 |
| Jun 5, 2015 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004.
The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfecta Terminated |
FEB | K140977 |
| Mar 23, 2015 | Advanced Sterilization Products Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Terminated |
FRG | K141693 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 100NX, Product Code 10144
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive re Terminated |
MLR | K111377 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD NX, Product Code 10133
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusa Terminated |
MLR | K042116 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 200, Product Code 10118
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reus Terminated |
MLR | K030429 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 100S, Product Code 10113.
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive re Terminated |
FLF | K023290 |
| Dec 22, 2014 | Advanced Sterilization Products STERRAD 50, Product Code 10114.
The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reus Terminated |
FLF | K023290 |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD 100S Sterilization System, Product Code: 10101
The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorg Terminated |
FLF | K023290 |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD 50 Sterilization System, Product Code: 10050
The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms Terminated |
FLF | K023290 |
| Jan 14, 2014 | Advanced Sterilization Products STERRAD NX Sterilization System, Product Code: 10033
The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganism Terminated |
MLR | K023290 K042116 |
| Dec 28, 2013 | Advanced Sterilization Products STERRAD Cyclesure Biological Indicator (BI, Part No. 14324.
Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Terminated |
FRC | K103222 |
| Dec 3, 2013 | Advanced Sterilization Products STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: Terminated |
FRG | K023614 K030853 +1 |
| Nov 26, 2013 | Advanced Sterilization Products STERRAD NX, Product Code: 10033
The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K042116 |
| Nov 26, 2013 | Advanced Sterilization Products STERRAD 100NX, Product Code: 10104
The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K071385 |
| Nov 8, 2013 | Advanced Sterilization Products Sterrad 100NX, Product Code: 10104.
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | None listed |
| Oct 22, 2013 | Advanced Sterilization Products STERRAD 200 Sterilizer (Single Door), Part Number: 10201.
STERRAD 200 Sterilizer (Double Door), Part Number: 10202.
The STERRAD Sterilization System is a low temperature general purpose sterilizer us Terminated |
MLR | K030429 |
| Oct 22, 2013 | Advanced Sterilization Products STERRAD 100NX Cassettes
The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K071385 |
| Sep 10, 2013 | Advanced Sterilization Products STERRAD 100NX Cassettes, Product Code: 10144
The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K071385 |
| Apr 26, 2013 | Advanced Sterilization Products STERRAD CYCLESURE 24 Biological Indicator (BI)
The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization Sys Terminated |
FRC | None listed |
| Apr 18, 2013 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004.
Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Terminated |
FEB | K082392 |
| Apr 15, 2013 | Advanced Sterilization Products EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004
Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. Terminated |
FEB | K082392 |
| Mar 30, 2013 | Advanced Sterilization Products STERRAD 200 Sterilization System, P/N 10201
Product Usage:
The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate micro Terminated |
MLR | K030429 |
| Mar 30, 2013 | Advanced Sterilization Products STERRAD 100NX Sterilization System, P/N 10104
Product Usage:
The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate Terminated |
MLR | K071385 |
| Mar 26, 2013 | Advanced Sterilization Products STERRAD 200 System Carriage, P/N 10208.
Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. Terminated |
MLR | K030429 |
| Jan 9, 2013 | Advanced Sterilization Products STERRAD NX Cassettes, P/N 10133.
The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The ster Terminated |
MLR | None listed |
| Dec 12, 2012 | Advanced Sterilization Products STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324.
Validation kits with Sterrad Cyclesure 24 BI products:
Codes/Serial Numbers, Product Description:
14324 Sterrad Cyclesure 24 Biol Terminated |
FRC | K103222 |
| Sep 7, 2012 | Advanced Sterilization Products STERRAD NX Cassette, Batch # 12A078.
The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medi Terminated |
MLR | K042116 |
| Sep 7, 2012 | Advanced Sterilization Products STERRAD 100S Cassette, Batch # 12A077.
The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable me Terminated |
MLR | K991999 |
| Aug 27, 2012 | Advanced Sterilization Products CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection. Terminated |
MED | K030004 |
| Jul 27, 2012 | Advanced Sterilization Products STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs.
The STERRAD CYCLESURE 24 Biological Indicator (BI) Terminated |
FRC | K103222 |
| Jun 6, 2012 | Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator, P/N: 14324
The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization Sy Terminated |
FRC | K103222 |
| Jan 13, 2012 | Advanced Sterilization Products STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used Terminated |
MLR | K030429 |
| Jan 11, 2012 | Advanced Sterilization Products STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133.
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture Terminated |
MLR | K042116 |
| Feb 22, 2011 | Advanced Sterilization Products Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332.
Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems. Terminated |
KCT | K951295 |
| Dec 16, 2010 | Advanced Sterilization Products ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301
The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes Terminated |
KOG | K832458 |
| Oct 20, 2009 | Advanced Sterilization Products Sterrad CycleSure Biological Indicator, Product Code 14324.
The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cy Terminated |
FRC | K031226 K994055 |
| Jun 30, 2009 | Advanced Sterilization Products Sterrad 50 Sterilizer, Product Code 10050.
Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K981625 |
| Jun 15, 2009 | Advanced Sterilization Products STERRAD NX Sterilization System Product Code 10033
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi Terminated |
MLR | K042116 |
| Jun 15, 2009 | Advanced Sterilization Products STERRAD 50 Sterilization System Product Code 10050
The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devi Terminated |
FLF | K023290 K981625 |
| Dec 2, 2008 | Advanced Sterilization Products STERRAD NX Sterilizer, Product Code 10033
Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments. Terminated |
MLR | K042116 |
| Nov 21, 2008 | Advanced Sterilization Products STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components.
The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to st Terminated |
MLR | K023290 K991999 |
| Nov 7, 2008 | Advanced Sterilization Products ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301
The AER is a machine designed to automatically wash and high-level disinfect flexible, subme Terminated |
FEB | K832458 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD 100NX Sterilizer, Product Code 10104
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K071385 |
| Aug 8, 2008 | Advanced Sterilization Products STERRAD NX Sterilizer, Product Code 10033
Used to sterilize heat and moisture sensitive reusable medical devices. Terminated |
MLR | K042116 |
Newest 50 of 69.