Panels › General Hospital › Product code MLR · Class 2
Sterilizer, Chemical
Regulation 880.6860
1510(k)s in 12 months (47 all time)
0recalls in 12 months (46 all time)
38recalls that name a 510(k)
Top companies in MLR
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Sterilization Products | 17 | 35 |
| STERIS Corporation | 20 | 11 |
| Plasmapp Co,., Ltd. | 4 | 0 |
| Sterilucent, Inc. | 2 | 0 |
| Ideate Medical, Inc. | 1 | 0 |
| Lowtem Co., Ltd. | 1 | 0 |
| Mdt Corp., Inc. | 1 | 0 |
| Mdt Biologic Co. | 1 | 0 |
| 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 |
| Sep 18, 2024 | K231893 | LOWTEM Crystal 120 Lowtem Co., Ltd., KR | MLR |
| 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 |
| Jun 27, 2024 | K233762 | SteroScope® Sterilization Technology System Ideate Medical, Inc. | MLR |
| Oct 20, 2023 | K233065 | V-PRO maX 2 Low Temperature Sterilization System Steris | MLR |
| Aug 7, 2023 | K223476 | V-PRO maX 2 Low Temperature Sterilization System STERIS Corporation | MLR |
| May 25, 2023 | K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT9 Plasmapp Co,., Ltd., KR | MLR |
| May 9, 2023 | K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette Plasmapp Co,., Ltd., KR | MLR |
| Apr 14, 2023 | K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Plasmapp Co,., Ltd., KR | MLR |
| Sep 9, 2022 | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System Steris | MLR |
| May 16, 2022 | K220404 | STERRAD NX with ALLClear Technology Advanced Sterilization Products, Inc. | MLR |
| Oct 22, 2021 | K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette Plasmapp Co,., Ltd., KR | MLR |
| Oct 9, 2021 | K212174 | STERRAD 100NX Sterilizer with ALLClear Technology Advanced Sterilization Products, Inc. | MLR |
| Sep 13, 2019 | K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer Sterilucent, Inc. | MLR |
| May 9, 2019 | K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems STERIS Corporation | MLR |
| Apr 5, 2019 | K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Tempe STERIS Corporation | MLR |
| Jan 3, 2019 | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System STERIS Corporation | MLR |
| Feb 9, 2018 | K172754 | V-PRO maX 2 Low Temperature Sterilization System STERIS Corporation | MLR |
| Jan 18, 2018 | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX L STERIS Corporation | MLR |
| Mar 31, 2017 | K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX L STERIS Corporation | MLR |
| 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 |
| Jul 6, 2016 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature STERIS Corporation | MLR |
| Jan 13, 2016 | K151725 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer Advanced Sterilization Products | MLR |
| Apr 3, 2015 | K142454 | STERRAD NX Sterilizer, STERRAD 100NX Sterilizer Advanced Sterilization Products | MLR |
| Oct 31, 2014 | K140464 | STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER Sterilucent, Inc. | MLR |
| Jul 24, 2014 | K140498 | V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Jul 16, 2013 | K131120 | AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Sep 13, 2012 | K111377 | STERRAD(R) 100NX STERILIZER DUO CYCLE Advanced Sterilization Products | MLR |
| Jun 26, 2012 | K120632 | AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Dec 1, 2011 | K112813 | AMSCO V-PRO Steris Corp | MLR |
| Nov 22, 2011 | K112760 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Sep 2, 2011 | K111810 | AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS STERIS Corporation | MLR |
| Aug 18, 2011 | K102394 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Aug 12, 2011 | K102330 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Mar 4, 2011 | K092622 | STERRAD 100NX STERILIZER EXPRESS CYCLE Advanced Sterilization Products | MLR |
| Aug 3, 2009 | K083097 | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Nov 29, 2007 | K071385 | STERRAD 100NX STERILIZER Advanced Sterilization Products | MLR |
| Oct 4, 2007 | K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM STERIS Corporation | MLR |
| Apr 22, 2005 | K042116 | STERRAD NX STERILIZER Advanced Sterilization Products | MLR |
| Aug 18, 2003 | K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products | MLR |
| Jun 15, 2000 | K991999 | STERRAD 100S STERILIZER Advanced Sterilization Products | MLR |
| Jan 11, 1999 | K981625 | STERRAD 50 STERILIZER Advanced Sterilization Products | MLR |
| Aug 2, 1995 | K943654 | HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS Mdt Biologic Co. | MLR |
| Feb 16, 1994 | K924380 | MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE Mdt Corp., Inc. | MLR |
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