ClearanceBrief
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

Company510(k)sRecalls
STERIS Corporation3511
3M320
Advanced Sterilization Products176
Raven Biological Laboratories, Inc.120
Spsmedical Supply Corp.90
Terragene62
Steritec Products Mfc. Co., Inc.06
3M Company - Health Care Business05
Andersen Sterilizers, Inc.50
Steritec Products Mfg Co, Inc.50
Decided510(k)Device and applicantCode
Apr 8, 2026K260766Celerity 5 HP Biological Indicator (LCB052)
STERIS Corporation
FRC
Sep 24, 2025K252680Celerity™ 20 HP Biological Indicator
STERIS Corporation
FRC
Aug 4, 2025K251122Terragene® Bionova® BT20 Biological Indicator
Terragene, AR
FRC
Jun 6, 2025K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator
Steris
FRC
Feb 6, 2025K250061Celerity Incubator
STERIS Corporation
FRC
Feb 6, 2025K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator
STERIS Corporation
FRC
Jan 28, 2025K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ A
3M Company
FRC
Dec 12, 2024K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon P
Terragene S.A., AR
FRC
Nov 25, 2024K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack
3M Company
FRC
Oct 18, 2024K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (49
3M Company
FRC
Sep 18, 2024K231383Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator
Terragene S.A., AR
FRC
Sep 12, 2024K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H;
3M Company
FRC
Jun 27, 2024K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)
3M Company
FRC
Jun 27, 2024K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indi
3M Company
FRC
Mar 15, 2024K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™
3M Company
FRC
Dec 15, 2023K233681ConFirm 20 Minute Incubator
STERIS Corporation
FRC
Aug 7, 2023K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
STERIS Corporation
FRC
Jun 15, 2023K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
STERIS Corporation
FRC
Jun 15, 2023K223715Celerity Incubator
STERIS Corporation
FRC
May 9, 2023K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), T
Plasmapp Co,., Ltd., KR
FRC
Feb 28, 2023K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene®
Terragene S.A., AR
FRC
Jul 21, 2022K213881Celerity Incubator
STERIS Corporation
FRC
Jun 28, 2022K2117053M Attest Rapid Readout Biological Indicator, 1295
3M Company
FRC
Apr 12, 2022K213296Anprolene SteriTest RRBI
Andersen Sterilizers, Inc.
FRC
Apr 6, 2022K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M
3M Company
FRC
Mar 18, 2022K220473CELERITY 20 HP Challenge Pack
Steris
FRC
Oct 22, 2021K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), T
Plasmapp Co,., Ltd., KR
FRC
Mar 24, 2021K203560STERIZONE VP4 Test Pack
Tso3 Inc., Now A Part of Stryker, CA
FRC
Mar 3, 2021K2102773M Attest Rapid Readout Biological Indicator, 1295
3M Company
FRC
Mar 3, 2021K202879EOGas 4 Endo-SteriTest RRBI
Andersen Sterilizers, Inc.
FRC
Jan 8, 2021K202721Celerity 20 Steam Biological Indicator for IUSS
STERIS Corporation
FRC
Dec 28, 2020K200970Self-Contained Biological Indicator
True Indicating, LLC
FRC
Dec 11, 2020K2009963M Attest Rapid Readout Biological Indicator
3M Company
FRC
Nov 12, 2020K192980EOGas 4 Endo-SteriTest
Andersen Sterilizers, Inc.
FRC
Jul 2, 2020K2007663M Attest Steam Chemical Integrator Test Pack
3M Company
FRC
Jun 5, 2020K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM
3M Company
FRC
Jun 1, 2020K2005363MTM AttestTM Rapid 5 Steam-Plus Test Pack
3M Complany
FRC
May 22, 2020K200126VERIFY Assert Self-Contained Biological Indicator
STERIS Corporation
FRC
Apr 15, 2020K2000923MTM AttestTM Mini Auto-reader 490M
3M
FRC
Feb 7, 2020K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack
3M Company
FRC
Jan 23, 2020K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
Advanced Sterilization Products (Asp)
FRC
Oct 22, 2019K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible
Sterilucent, Inc.
FRC
Sep 13, 2019K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
Terragene S.A., AR
FRC
May 14, 2019K190297Celerity HP Incubator
STERIS Corporation
FRC
Jan 3, 2019K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
Steris Corporations
FRC
Jan 3, 2019K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
STERIS Corporation
FRC
Dec 27, 2018K182404STERRAD VELOCITY Biological Indicator
Advanced Sterilization Products (Asp)
FRC
Nov 20, 2018K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-
Steris Corporations
FRC
Nov 14, 2018K181434SporView Rapid Read Biological Indicator SteamPlus Test Pack
Crosstex/Spsmedical, A Division of Cantel Medical
FRC
Jul 24, 2018K181686CELERITY 20 Steam Biological Indicator
STERIS Corporation
FRC

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