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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)
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Top companies in FRC

DateFirm and productCodeLinked 510(k)
Oct 2, 2026Steris Corporation
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Open, Classified
FRCK854902
Oct 2, 2026Steris Corporation
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Open, Classified
FRCK854902
Oct 2, 2026Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Open, Classified
FRCK083665
Oct 2, 2026Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Open, Classified
FRCK083665
Oct 2, 2026Steris Corporation
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Open, Classified
FRCK854902
Oct 2, 2026Steris Corporation
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
Open, Classified
FRCK854902
Jun 5, 2026HF 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
FRCK032914
K050591
Jun 5, 2026HF 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
FRCK032914
K050591
Feb 27, 2025TERRAGENE S.A.
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Open, Classified
FRCK163646
Feb 11, 2025HF 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
FRCK023716
K041099 +1
Jan 26, 2024TERRAGENE S.A.
Terragene Bionova PCD (PCD222-C)
Open, Classified
FRCK163646
Sep 26, 20233M 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
FRCK193154
Sep 26, 20233M 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
FRCK193154
Sep 26, 20233M 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
FRCK173519
Sep 26, 20233M 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
FRCK173437
Jan 3, 2023Steris 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
FRCK083665
Jan 3, 2023Steris 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
FRCK083665
Jan 3, 2023Steris 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
FRCK083665
Jan 3, 2023Steris 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
FRCK083665
Sep 26, 2022Mckesson 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
FRCK070461
K152630 +3
Sep 26, 2022Mckesson 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
FRCK905425
Feb 12, 2018Mesa Laboratories Bozeman Manufacturing Facility
SporAmpule Biological Indicator Catalog Number SPS5-100
Terminated
FRCK971432
Feb 12, 2018Mesa Laboratories Bozeman Manufacturing Facility
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Terminated
FRCK971432
Apr 4, 2016Mesa 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
FRCK971432
Jul 7, 20143M 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
FRCK103277
K123546
Dec 28, 2013Steris 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
FRCK083665
K854631 +1
Dec 28, 2013Advanced 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
FRCK103222
Aug 21, 2013Getinge 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
FRCK093794
Aug 1, 2013Mesa 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
FRCK093794
Aug 1, 2013Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Terminated
FRCK930682
K963841
Jul 29, 2013Steritec 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
FRCK111150
Jul 29, 2013Steritec 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
FRCK111150
Jul 29, 2013Steritec 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
FRCK111150
Jul 29, 2013Steritec 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
FRCK930682
Jul 29, 2013Steritec 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
FRCK930682
Jul 29, 2013Steritec 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
FRCK930682
Apr 26, 2013Advanced 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
FRCNone listed
Dec 12, 2012Advanced 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
FRCK103222
Jul 27, 2012Advanced 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
FRCK103222
Jun 6, 2012Advanced 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
FRCK103222
Oct 20, 2009Advanced 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
FRCK031226
K994055
Nov 29, 2005Namsa
Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.
Terminated
FRCK994381
Jul 20, 20043M 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
FRCNone listed
Dec 18, 20033m Health Care
3M Attest 1264P Biological Indicators, in boxes of 25 per box
Terminated
FRCNone listed
Dec 18, 20033m Health Care
3M Attest 1264 Biological Indicators, in boxes of 100 per box
Terminated
FRCNone listed
Apr 22, 20033m Health Care
N/A
Terminated
FRCNone listed

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