Panels › General Hospital › Product code FRC · Class 2
Indicator, Biological Sterilization Process
Regulation 880.2800
1510(k)s in 12 months (206 all time)
8recalls in 12 months (46 all time)
41recalls that name a 510(k)
Top companies in FRC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3069 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological Steam Test Pack
Model/Catalog Number: S3065 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3061 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator
Model/Catalog Number: S3060 Open, Classified |
FRC | K083665 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB007 Open, Classified |
FRC | K854902 |
| Oct 2, 2026 | Steris Corporation VERIFY Biological/Integrator Challenge Pack
Model/Catalog Number: LCB006 Open, Classified |
FRC | K854902 |
| Jun 5, 2026 | HF Acquisition Co LLC Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS
Model/Catalog Number: 1023770
Software Version: N/A
Product Description: T Open, Classified |
FRC | K032914 K050591 |
| Jun 5, 2026 | HF Acquisition Co LLC Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Model/Catalog Number: 1023780
Software Version: N/A
Product Description: T Open, Classified |
FRC | K032914 K050591 |
| Feb 27, 2025 | TERRAGENE S.A. ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. Open, Classified |
FRC | K163646 |
| Feb 11, 2025 | HF Acquisition Co LLC Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.
Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580 Open, Classified |
FRC | K023716 K041099 +1 |
| Jan 26, 2024 | TERRAGENE S.A. Terragene Bionova PCD (PCD222-C) Open, Classified |
FRC | K163646 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | K193154 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | K193154 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | K173519 |
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or
monitor dynamic-air-removal steam sterilization cycles Open, Classified |
FRC | K173437 |
| Jan 3, 2023 | Steris Corporation VERIFY Steam Test Pack (20 Tests and 20 controls)
Item Number: S3069
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes Open, Classified |
FRC | K083665 |
| Jan 3, 2023 | Steris Corporation VERIFY Steam Test Pack (20 Tests and 5 controls)
Item Number: S3065
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes Open, Classified |
FRC | K083665 |
| Jan 3, 2023 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicators, 100 per box
Item Number: S3061
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proc Open, Classified |
FRC | K083665 |
| Jan 3, 2023 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicators, 50 per box
Item Number: S3060
Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proce Open, Classified |
FRC | K083665 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053.
b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/ Open, Classified |
FRC | K070461 K152630 +3 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020
b. SPORVIEW CULTURE SET SporView Sterilization Biological Indi Open, Classified |
FRC | K905425 |
| Feb 12, 2018 | Mesa Laboratories Bozeman Manufacturing Facility SporAmpule Biological Indicator Catalog Number SPS5-100 Terminated |
FRC | K971432 |
| Feb 12, 2018 | Mesa Laboratories Bozeman Manufacturing Facility ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471 Terminated |
FRC | K971432 |
| Apr 4, 2016 | Mesa Laboratories Inc ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box.
Product Usage:
Biological indicator f Terminated |
FRC | K971432 |
| Jul 7, 2014 | 3M Company - Health Care Business 3M Attest Auto-reader. Model numbers 390, 390G,and 490.
These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle. Terminated |
FRC | K103277 K123546 |
| Dec 28, 2013 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH.
Intended for use in installation testing and routine monitoring of steam sterilization and ethy Terminated |
FRC | K083665 K854631 +1 |
| 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 |
| Aug 21, 2013 | Getinge USA Inc Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 1462 Terminated |
FRC | K093794 |
| Aug 1, 2013 | Mesa Laboratories, Inc., Bozeman Manufacturing Facility Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM.
Intended for use in determining the efficacy of steam sterilization processes. Terminated |
FRC | K093794 |
| Aug 1, 2013 | Mesa Laboratories, Inc., Bozeman Manufacturing Facility Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM.
Intended for use in determining the efficacy of steam sterilization processes. Terminated |
FRC | K930682 K963841 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25
The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed spec Terminated |
FRC | K111150 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639
The Smart-Read Biological Test Pack with Instant Readout Integrator: is desi Terminated |
FRC | K111150 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638
The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed Terminated |
FRC | K111150 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended fo Terminated |
FRC | K930682 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biol Terminated |
FRC | K930682 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Bio Terminated |
FRC | K930682 |
| 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 |
| 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 |
| 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 |
| 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 |
| Nov 29, 2005 | Namsa Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. Terminated |
FRC | K994381 |
| Jul 20, 2004 | 3M Company / Medical Division 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box Terminated |
FRC | None listed |
| Dec 18, 2003 | 3m Health Care 3M Attest 1264P Biological Indicators, in boxes of 25 per box Terminated |
FRC | None listed |
| Dec 18, 2003 | 3m Health Care 3M Attest 1264 Biological Indicators, in boxes of 100 per box Terminated |
FRC | None listed |
| Apr 22, 2003 | 3m Health Care N/A Terminated |
FRC | None listed |
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