Indicator, Biological Sterilization Process
FDA product code FRC · Class II (moderate risk) · 21 CFR 880.2800 · General Hospital
206510(k) clearances
0PMA approvals
35recalls
Manufacturers
- STERIS Corporation 35
- 3M Company 31
- Advanced Sterilization Products 17
- Raven Biological Laboratories, Inc. 12
- Spsmedical Supply Corp. 9
- Andersen Sterilizers, Inc. 5
- Surgicot, Inc. 5
- Steritec Products Mfg Co, Inc. 5
- Terragene S.A. 5
- Mdt Corp., Inc. 4
- Propper Mfg. Co., Inc. 4
- Pymah Corp. 4
- Sgm Biotech, Inc. 4
- Dana Products, Inc. 3
- Pymah Corp., Ati Div. 3
- Advanced Sterilization Products (Asp) 3
- Skyland Scientific Services, Inc. 3
- Castle Co. 3
- North American Science Assoc., Inc. 3
- Mesa Laboratories, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova®…FRC · Traditional | Terragene S.A. | 09/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 3M Company | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 3M Company | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 3M Company | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 3M Company | 03/15/2024SE |
| K233681 | ConFirm 20 Minute IncubatorFRC · Special | STERIS Corporation | 12/15/2023SE |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological IndicatorFRC · Traditional | STERIS Corporation | 08/07/2023SE |
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackFRC · Traditional | STERIS Corporation | 06/15/2023SE |
| K223715 | Celerity IncubatorFRC · Traditional | STERIS Corporation | 06/15/2023SE |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…FRC · Traditional | Plasmapp Co,., Ltd. | 05/09/2023SE |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper…FRC · Traditional | Terragene S.A. | 02/28/2023SE |
| K213881 | Celerity IncubatorFRC · Traditional | STERIS Corporation | 07/21/2022SE |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295FRC · Special | 3M Company | 06/28/2022SE |
| K213296 | Anprolene SteriTest RRBIFRC · Traditional | Andersen Sterilizers, Inc. | 04/12/2022SE |
| K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge…FRC · Traditional | 3M Company | 04/06/2022SE |
| K220473 | CELERITY 20 HP Challenge PackFRC · Special | Steris | 03/18/2022SE |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…FRC · Traditional | Plasmapp Co,., Ltd. | 10/22/2021SE |
| K203560 | STERIZONE VP4 Test PackFRC · Traditional | Tso3 Inc., Now A Part of Stryker | 03/24/2021SE |
| K210277 | 3M Attest Rapid Readout Biological Indicator, 1295FRC · Special | 3M Company | 03/03/2021SE |
| K202879 | EOGas 4 Endo-SteriTest RRBIFRC · Traditional | Andersen Sterilizers, Inc. | 03/03/2021SE |
| K202721 | Celerity 20 Steam Biological Indicator for IUSSFRC · Traditional | STERIS Corporation | 01/08/2021SE |
| K200970 | Self-Contained Biological IndicatorFRC · Traditional | True Indicating, LLC | 12/28/2020SE |
| K200996 | 3M Attest Rapid Readout Biological IndicatorFRC · Traditional | 3M Company | 12/11/2020SE |
| K192980 | EOGas 4 Endo-SteriTestFRC · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K200766 | 3M Attest Steam Chemical Integrator Test PackFRC · Traditional | 3M Company | 07/02/2020SE |
| K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid…FRC · Traditional | 3M Company | 06/05/2020SE |
| K200536 | 3MTM AttestTM Rapid 5 Steam-Plus Test PackFRC · Traditional | 3M Complany | 06/01/2020SE |
| K200126 | VERIFY Assert Self-Contained Biological IndicatorFRC · Traditional | STERIS Corporation | 05/22/2020SE |
| K200092 | 3MTM AttestTM Mini Auto-reader 490MFRC · Traditional | 3M | 04/15/2020SE |
| K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge PackFRC · Traditional | 3M Company | 02/07/2020SE |
| K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderFRC · Traditional | Advanced Sterilization Products (Asp) | 01/23/2020SE |
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process…FRC · Traditional | Sterilucent, Inc. | 10/22/2019SE |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene…FRC · Traditional | Terragene S.A. | 09/13/2019SE |
| K190297 | Celerity HP IncubatorFRC · Traditional | STERIS Corporation | 05/14/2019SE |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…FRC · Traditional | Steris Corporations | 01/03/2019SE |
| K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackFRC · Traditional | STERIS Corporation | 01/03/2019SE |
| K182404 | STERRAD VELOCITY Biological IndicatorFRC · Traditional | Advanced Sterilization Products (Asp) | 12/27/2018SE |
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack…FRC · Special | Steris Corporations | 11/20/2018SE |
| K181434 | SporView Rapid Read Biological Indicator SteamPlus Test PackFRC · Traditional | Crosstex/Spsmedical, A Division of Cantel Medical | 11/14/2018SE |
| K181686 | CELERITY 20 Steam Biological IndicatorFRC · Special | STERIS Corporation | 07/24/2018SE |
| K181429 | CELERITY 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 06/13/2018SE |
| K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus…FRC · Traditional | 3M Company | 04/23/2018SE |
| K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M…FRC · Traditional | 3M Company | 03/19/2018SE |
| K173488 | CELERITY 20 HP Challenge PackFRC · Traditional | STERIS Corporation | 03/01/2018SE |
| K173633 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack…FRC · Traditional | STERIS Corporation | 02/28/2018SE |
| K173629 | CELERITY 20 Steam Process Challenge Device for Gravity CyclesFRC · Traditional | STERIS Corporation | 02/21/2018SE |
| K173626 | Celerity 20 Steam Process Challenge Device for Dynamic Air Removal CyclesFRC · Traditional | STERIS Corporation | 02/21/2018SE |
| K173670 | CELERITY 20 Steam IncubatorFRC · Traditional | STERIS Corporation | 02/12/2018SE |
| K173634 | CELERITY 20 Steam Biological IndicatorFRC · Traditional | STERIS Corporation | 02/12/2018SE |
| K173435 | 3M Attest Rapid Readout Biological IndicatorFRC · Traditional | 3M Company | 02/09/2018SE |
| K172752 | CELERITY 20 HP Biological IndicatorFRC · Traditional | STERIS Corporation | 02/09/2018SE |
| K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…FRC · Traditional | Steris Corporations | 02/09/2018SE |
| K171287 | Sporview VH202 BIFRC · Traditional | Spsmedical Supply Corp. A Division of Cantel… | 02/01/2018SE |
| K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest…FRC · Traditional | 3M Company | 01/22/2018SE |
| K172474 | Celerity 20 HP Biological IndicatorFRC · Traditional | STERIS Corporation | 12/29/2017SE |
| K172432 | SporView Rapid Read Biological IndicatorFRC · Traditional | Crosstex/Spsmedical, A Division of Cantel Medical | 12/12/2017SE |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD…FRC · Traditional | Terragene S.A. | 11/02/2017SE |
| K170427 | Anprolene SteriTestFRC · Traditional | Andersen Sterilizers, Inc. | 10/31/2017SE |
| K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorFRC · Traditional | STERIS Corporation | 08/22/2017SE |
| K171504 | VERIFY Assert VH2O2 Self-Contained Biological IndicatorFRC · Traditional | STERIS Corporation | 08/22/2017SE |
| K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-readerFRC · Traditional | 3M Company | 07/21/2017SE |
| K170039 | STERRAD VELOCITY Biological Indictator and ReaderFRC · Traditional | Advanced Sterilization Products (Asp) | 06/20/2017SE |
| K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity CyclesFRC · Traditional | STERIS Corporation | 04/28/2017SE |
| K163144 | gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)FRC · Traditional | Gke-GmbH | 04/07/2017SE |
| K160546 | 3M Attest Rapid Readout Biological IndicatorFRC · Traditional | 3M Company | 06/09/2016SE |
| K151482 | BCR-30-min BI and RBIP-ST30 Readout AccessoryFRC · Traditional | Bcr Diagnostics, Inc. | 02/26/2016SE |
| K152060 | 3M Attest Rapid Readout Biological Indicator 1295FRC · Traditional | 3M Company | 12/01/2015SE |
| K151585 | Andersen EOGas 4 SteriTestFRC · Traditional | Andersen Sterilizers, Inc. | 11/18/2015SE |
| K151971 | STERRAD CYCLESURE 24 Biological IndicatorFRC · Traditional | Advanced Sterilization Products | 10/29/2015SE |
| K141580 | Sterizone Self-Contained Biological IndicatorFRC · Traditional | Tso3, Inc. | 12/17/2014SE |
| K140589 | Sterrad Cyclesure 24 Plus Biological IndicatorFRC · Traditional | Mesa Laboratories, Inc. | 12/03/2014SE |
| K141238 | Sterilucent Self-Contained Biological IndicatorFRC · Traditional | Sterilucent, Inc. | 11/03/2014SE |
| K141312 | Sterilucent Process Challenge DeviceFRC · Traditional | Sterilucent, Inc. | 10/31/2014SE |
| K141244 | Namsa Biological Indicator Spore Strips (Dual Species) Namsa Biological Indicator Spore…FRC · Traditional | North American Science Assoc., Inc. | 09/09/2014SE |
| K133549 | Steritec Biological Test Pack with Instant Readout IntegratorFRC · Traditional | Steritec Products Mfg Co, Inc. | 08/27/2014SE |
| K133322 | Steritec Smart-Read Biological Test Pack with Instant Readout IntegratorFRC · Traditional | Steritec Products Mfg Co, Inc. | 08/25/2014SE |
| K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-ReaderFRC · Traditional | 3M Company | 08/13/2014SE |
| K140620 | Sporview Plus Bi Test PackFRC · Traditional | Crosstex International | 08/07/2014SE |
| K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesFRC · Traditional | STERIS Corporation | 07/17/2014SE |
| K140708 | Verify V24 Self-Contained Biological IndicatorFRC · Traditional | STERIS Corporation | 06/16/2014SE |
| K130263 | Sterrad 50/100S/200 Test PackFRC · Traditional | Advanced Sterilization Products | 03/28/2014SE |
| K133267 | Dana Reusable Test PackFRC · Traditional | Dana Products, Inc. | 02/11/2014SE |
| K122024 | Spsmedical Sporview 10 Steam Self Contained Biological IndicatorFRC · Traditional | Spsmedical Supply Corp. | 11/26/2013SE |
| K122362 | Smart-Well IncubatorFRC · Special | Mesa Laboratories, Inc. | 03/26/2013SE |
| K123546 | 3M Attest(Tm) Auto-ReaderFRC · Traditional | 3M Company | 03/18/2013SE |
| K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest(Tm) Super Rapid 5…FRC · Traditional | 3M Company | 03/15/2013SE |
| K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324FRC · Special | Advanced Sterilization Products | 12/26/2012SE |
| K121484 | 3M Attest(Tm) Super Rapid Readout Biological Indicator, 3M Attest(Tm) Auto-ReaderFRC · Traditional | 3M Company | 10/19/2012SE |
| K122044 | Sterrad(R) Cyclesure(R) 24 Biological IndicatorFRC · Special | Advanced Sterilization Products | 10/04/2012SE |
| K111391 | Sterrad (R) 100NX Duo Cycle Test PackFRC · Traditional | Advanced Sterilization Products | 09/26/2012SE |
| K111375 | Sterrad (R) Cyclesure (R) 24 Biological IndicatorFRC · Traditional | Advanced Sterilization Products | 09/14/2012SE |
| K113221 | Namsa Biological Indicator Spore StripsFRC · Traditional | North American Science Assoc., Inc. | 04/27/2012SE |
| K111515 | Spsmedical Sporview Steam BiFRC · Traditional | Spsmedical Supply Corp. | 02/01/2012SE |
| K112018 | Smart Read Eztest SteamFRC · Traditional | Mesa Laboratories, Inc. | 01/30/2012SE |
| K113302 | Namsa Steam Self-Contained Biological IndicatorsFRC · Abbreviated | North American Science Assoc., Inc. | 01/20/2012SE |
| K111150 | Steritec Smart-Read Biological Test Pack with Instant Readout IntegratorFRC · Traditional | Steritec Products Mfg Co, Inc. | 07/08/2011SE |
| K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-ReaderFRC · Traditional | 3M Company-3M Health Care | 04/19/2011SE |
| K103222 | Sterrad Cyclesure Biological IndicatorFRC · Traditional | Advanced Sterilization Products | 02/25/2011SE |
| K092755 | Sterraad 100NX Express Cycle Test PackFRC · Traditional | Advanced Sterilization Products | 02/25/2011SE |
| K103321 | Dana Reusable Testpack for Steam Sterilization for 10 Minute Extended CyclesFRC · Traditional | Dana Products, Inc. | 02/16/2011SE |
| K102884 | Sterrad Cyclesure 24 Biological IndicatorFRC · Traditional | Advanced Sterilization Products | 01/28/2011SE |
| K101910 | 3M Attest Rapid Readout Steam Process Challenge Device, Model 1296V, 3M Attest Rapid…FRC · Traditional | 3M Company | 12/08/2010SE |
| K093794 | Smart-Read Eztest-Steam Scbi and Test PackFRC · Special | Sgm Biotech, Inc. | 05/14/2010SE |
| K092944 | Dana Reusable Test Pack for Steam SterilizationFRC · Traditional | Dana Products, Inc. | 03/18/2010SE |
| K091950 | Smart-Well Eztest IncubatorFRC · Traditional | Sgm Biotech, Inc. | 01/15/2010SE |
| K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationFRC · Traditional | STERIS Corporation | 12/30/2009SE |
| K082756 | Raven Protest - Steam Biological IndicatorFRC · Traditional | Raven Biological Laboratories, Inc. | 10/21/2009SE |
| K083665 | Verify Scbi 275F 3-10FRC · Abbreviated | STERIS Corporation | 09/01/2009SE |
| K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292FRC · Special | 3M Company | 04/29/2009SE |
| K090514 | Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization ProcessesFRC · Special | STERIS Corporation | 03/16/2009SE |
| K073618 | Verify Sirius Biological Indicator Challenge PackFRC · Traditional | STERIS Corporation | 01/07/2009SE |
| K073244 | Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization ProcessesFRC · Traditional | STERIS Corporation | 05/28/2008SE |
| K071537 | Sterrad 100NX Test PackFRC · Traditional | Advanced Sterilization Products | 12/18/2007SE |
| K071014 | Modification to Sterrad Cyclesure Biological IndicatorFRC · Special | Advanced Sterilization Products | 05/24/2007SE |
| K070595 | Sporview Steam Self-Contained Biological IndicatorFRC · Traditional | Spsmedical Supply Corp. | 05/24/2007SE |
| K051056 | Verify Self-Contained Biological IndicatorFRC · Traditional | Albert Browne , Ltd. | 10/20/2005SE |
| K051643 | Sterrad Sterilizer Cyclesure Test PackFRC · Traditional | Advanced Sterilization Products | 08/19/2005SE |
| K052128 | 3M Attest 293 Auto-Reader, 3M Attest 293G Auto-ReaderFRC · Special | 3M Company | 08/16/2005SE |
| K051173 | Spsmedical Sporview Plus Steam Bi Test PackFRC · Special | Spsmedical Supply Corp. | 05/27/2005SE |
| K042450 | Sterrad NX Challenge PackFRC · Traditional | Advanced Sterilization Products | 05/12/2005SE |
| K050664 | Spor-Test Pa Biological Indicator KitFRC · Special | Getinge USA, Inc. | 04/07/2005SE |
| K050591 | Modification to Raven Bacterial Spore StripsFRC · Special | Raven Biological Laboratories, Inc. | 03/23/2005SE |
| K041784 | Raven Protest - EoFRC · Traditional | Raven Biological Laboratories, Inc. | 09/13/2004SE |
| K041386 | Raven Protest - SteamFRC · Traditional | Raven Biological Laboratories, Inc. | 08/09/2004SE |
| K032914 | Modification To:Raven Bacterial Spore StripsFRC · Traditional | Raven Biological Laboratories, Inc. | 05/25/2004SE |
| K041099 | Modification to Spsmedical Sporview Bacterial Spore StripFRC · Special | Spsmedical Supply Corp. | 05/06/2004SE |
| K031012 | Attest Rapid Readout Biological Indicator for Eo, Model 1294; Attest Rapid Readout…FRC · Traditional | 3M Company | 10/16/2003SE |
| K032723 | Biosign STEAM-24 Biological IndicatorFRC · Special | Getinge USA, Inc. | 10/01/2003SE |
| K031226 | Sterrad Cyclesure Biological IndicatorFRC · Special | Advanced Sterilization Products | 05/02/2003SE |
| K024079 | Alibi Biological Indicator, Model WSFRC · Abbreviated | Arden Laboratories, Incorporated | 02/27/2003SE |
| K023716 | Spsmedical Sporview Bacterial Spore StripFRC · Special | Spsmedical Supply Corp. | 12/05/2002SE |
| K022706 | Spsmedical Sporview Steam Bi Test PackFRC · Traditional | Spsmedical Supply Corp. | 10/25/2002SE |
| K020205 | Castle Peracetic Acid Biological Indicator KitFRC · Traditional | Getinge/Castle, Inc. | 06/24/2002SE |
| K004009 | 3M Attest 290 Auto-ReaderFRC · Traditional | 3M Company | 03/25/2002SE |
| K994055 | Sterrad Cyclesure Biological IndicatorFRC · Traditional | Advanced Sterilization Products | 02/13/2002SE |
| K020026 | Raven Bacterial Spore StripsFRC · Special | Raven Biological Laboratories, Inc. | 01/30/2002SE |
| K994381 | PROSPORE2 Self-Contained Biological IndicatorFRC · Traditional | Raven Biological Laboratories, Inc. | 03/30/2001SE |
| K991618 | Bi-O.K. Self-Contained Biological IndicatorFRC · Traditional | Propper Mfg. Co., Inc. | 01/24/2001SE |
| K993775 | Sterrad Bi Test PackFRC · Traditional | Advanced Sterilization Products | 06/01/2000SE |
| K991675 | Modification of: Sterrad Bi Test PackFRC · Special | Advanced Sterilization Products | 06/15/1999SE |
| K981497 | Steritec Disposable Biological Test Pack-Eo GasFRC · Traditional | Steritec Products Mfg Co, Inc. | 10/29/1998SE |
| K972747 | Bi-O.K. Eo Gas Biological Test-Pak (269305,269310,269320)FRC · Traditional | Propper Mfg. Co., Inc. | 01/09/1998SE |
| K971430 | Prospore IIFRC · Traditional | Raven Biological Laboratories, Inc. | 05/22/1997SE |
| K971432 | ProsporeFRC · Traditional | Raven Biological Laboratories, Inc. | 05/20/1997SE |
| K930683 | Eztest-GasFRC · Traditional | Sgm Biomedical, Inc. | 03/04/1997SE |
| K963841 | EztestFRC · Traditional | Sgm Biotech, Inc. | 02/25/1997SE |
| K962441 | Prospore(Stearo for Steam Sterilizer)FRC · Traditional | Raven Biological Laboratories, Inc. | 09/18/1996SE |
| K961721 | Steritec Disposable Biological Test PackFRC · Traditional | Steritec Products Mfg Co, Inc. | 08/23/1996SE |
| K960790 | Prospore IIFRC · Traditional | Raven Biological Laboratories, Inc. | 08/16/1996SE |
| K960777 | MDT Unispore and Spor-Test BiologicalindicatorFRC · Traditional | Mdt Corp., Inc. | 05/23/1996SE |
| K926364 | Attest Brand Rapid Readout Biological Ind. #129XFRC · Traditional | 3M Health Care, Ltd. | 03/31/1995SE |
| K923739 | Abtox Serilization Process Biological IndicatorFRC · Traditional | Abtox, Inc. | 12/22/1994SE |
| K930682 | Eztest-SteamFRC · Traditional | Sgm Biotech, Inc. | 04/04/1994SE |
| K925745 | Ati(R) Disp Biological-Plus Test PackFRC · Traditional | Pymah Corp. | 02/01/1994SE |
| K925496 | Ati Disposable Biological-Plus Test PackFRC · Traditional | Pymah Corp. | 02/01/1994SE |
| K921909 | Sterrad Bi Test PackFRC · Traditional | Johnson & Johnson Medical, Inc. | 10/01/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | Mdt Corp., Inc. | 08/10/1992SE |
| K912796 | Spore StripFRC · Traditional | Raven Biological Laboratories, Inc. | 04/02/1992SE |
| K905425 | SporviewFRC · Traditional | Spsmedical Supply Corp. | 03/27/1992SE |
| K910417 | Evidence Biological IndicatorFRC · Traditional | Skyland Scientific Services, Inc. | 03/08/1991SE |
| K903024 | Bi-O.K. Steam Test-PakFRC · Traditional | Propper Mfg. Co., Inc. | 09/12/1990SE |
| K902344 | Ati Disposable Biological Test Pack for Steam SterFRC · Traditional | Ati | 07/19/1990SE |
| K900771 | Attest Brand Rapid Readout Biological IndicatorFRC · Traditional | 3M Company | 07/03/1990SE |
| K895704 | Ati Disp. Biological Test Pack for Ethylene OxideFRC · Traditional | Pymah Corp., Ati Div. | 03/08/1990SE |
| K891784 | Bi-O.K.(Tm)-Biological/Chemical IndicatorFRC · Traditional | Propper Mfg. Co., Inc. | 02/09/1990SE |
| K890754 | Sporview Culture MediaFRC · Traditional | Spsmedical Supply Corp. | 11/17/1989SE |
| K894399 | Sterigage Integrator Test Pack for Steam Sterili.FRC · Traditional | Pymah Corp. | 09/11/1989SE |
| K894398 | Sterigage Integrator Test Pack for Ethylene OxideFRC · Traditional | Pymah Corp. | 09/11/1989SE |
| K891366 | Biosign Biological Indicator (Eight Month Exp.)FRC · Traditional | Mdt Corp., Inc. | 03/29/1989SE |
| K884615 | Ati-Pymah Disposable Steam Biological Test PackFRC · Traditional | Pymah Corp., Ati Div. | 01/19/1989SE |
| K884767 | Ati-Pymah Disposable Biological Test PackFRC · Traditional | Pymah Corp., Ati Div. | 01/10/1989SE |
| K872867 | BiosignFRC · Traditional | Clinical Technology Corp. | 07/06/1988SE |
| K863122 | Assert Biological/Chemical Indicator 12 Month Exp.FRC · Traditional | Surgicot, Inc. | 12/17/1986SE |
| K855101 | Assert TM Biological/Chemical IndicatorFRC · Traditional | Surgicot, Inc. | 07/17/1986SE |
| K855120 | Ati Disposable Biological Test PackFRC · Traditional | Parke-Davis Co. | 06/18/1986SE |
| K854631 | Assert Eo Biological Test PackFRC · Traditional | Surgicot, Inc. | 05/27/1986SE |
| K854902 | Surgicot Steam Test PackFRC · Traditional | Surgicot, Inc. | 05/20/1986SE |
| K844479 | ChemsporFRC · Traditional | American Sterilizer Co. | 11/25/1985SN |
| K852192 | Disposable Steam Biological Test PackFRC · Traditional | Parke-Davis Co. | 11/01/1985SE |
| K850144 | Biological/Chemical Indicator Proof FlashFRC · Traditional | American Sterilizer Co. | 06/17/1985SE |
| K841709 | 48 Hour Biological Indicators SporstripFRC · Traditional | Skyland Scientific Services, Inc. | 10/02/1984SE |
| K841583 | SporstripFRC · Traditional | Skyland Scientific Services, Inc. | 05/25/1984SE |
| K832922 | Travaspore Biological IndicatorFRC · Traditional | Travenol Laboratories, S.A. | 11/21/1983SE |
| K822024 | Bacillu S Subtilis Biological Indica.FRC · Traditional | Findley Research, Inc. | 07/22/1982SE |
| K812272 | Castle Tec-Test Biological IndicatorFRC · Traditional | Sybron Corp. | 09/08/1981SE |
| K810930 | Bacillum Pumilus Spore StripsFRC · Traditional | Oxoid U.S.A., Inc. | 06/16/1981SE |
| K802228 | Biological Indicator - Kemmed & BiosureFRC · Traditional | Kem Medical Products Corp. | 12/09/1980SE |
| K801678 | Spor-Test-StripFRC · Traditional | Sterilization Technical Services, Inc. | 08/13/1980SE |
| K800482 | Stearothermohilus Spore StripsFRC · Traditional | Mdt Corp., Inc. | 04/16/1980SE |
| K800029 | Surgicot 2 Indicator SystemFRC · Traditional | Surgicot, Inc. | 03/12/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2332-2026 Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ…Due to incorrect incubation process being performed on product. | HF Acquisition Co LLC | 04/13/2026Open, Classified |
| Z-2331-2026 Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ…Due to incorrect incubation process being performed on product. | HF Acquisition Co LLC | 04/13/2026Open, Classified |
| Z-1248-2025 Class II | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct… | Terragene S.A. | 01/15/2025Open, Classified |
| Z-1141-2025 Class II | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.…Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a… | HF Acquisition Co LLC | 12/11/2024Open, Classified |
| Z-0837-2024 Class II | Terragene Bionova PCD (PCD222-C)Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with… | Terragene S.A. | 12/07/2023Open, Classified |
| Z-2640-2023 Class II | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 3M Company - Health Care Business | 08/22/2023Open, Classified |
| Z-2639-2023 Class II | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 3M Company - Health Care Business | 08/22/2023Open, Classified |
| Z-2638-2023 Class II | 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 3M Company - Health Care Business | 08/22/2023Open, Classified |
| Z-2637-2023 Class II | 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 3M Company - Health Care Business | 08/22/2023Open, Classified |
| Z-0781-2023 Class II | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | Steris Corporation | 12/12/2022Open, Classified |
| Z-0780-2023 Class II | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | Steris Corporation | 12/12/2022Open, Classified |
| Z-0779-2023 Class II | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | Steris Corporation | 12/12/2022Open, Classified |
| Z-0778-2023 Class II | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | Steris Corporation | 12/12/2022Open, Classified |
| Z-1793-2022 Class III | a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1790-2022 Class III | a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas /…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1274-2018 Class II | SporAmpule Biological Indicator Catalog Number SPS5-100The concentration of bromocresol purple in the recalled lots does not conform to specification. | Mesa Laboratories Bozeman Manufacturing… | 02/12/2018Terminated |
| Z-1273-2018 Class II | ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471The concentration of bromocresol purple in the recalled lots does not conform to specification. | Mesa Laboratories Bozeman Manufacturing… | 02/12/2018Terminated |
| Z-1104-2017 Class II | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus…Product resistance has fallen outside of label claim within expiry. | Mesa Laboratories Inc | 04/04/2016Terminated |
| Z-2002-2014 Class II | 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the…Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry… | 3M Company - Health Care Business | 06/09/2014Terminated |
| Z-0604-2014 Class II | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a…Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because… | Advanced Sterilization Products | 11/26/2013Terminated |
| Z-0605-2014 Class II | VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS…STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM… | Steris Corporation | 09/10/2013Terminated |
| Z-1994-2013 Class II | Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and…AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This… | Getinge USA Inc | 08/02/2013Terminated |
| Z-1827-2013 Class II | Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25…Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the… | Steritec Products Mfc. Co., Inc. | 06/10/2013Terminated |
| Z-1826-2013 Class II | Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25…Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the… | Steritec Products Mfc. Co., Inc. | 06/10/2013Terminated |
| Z-1825-2013 Class II | Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395…Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the… | Steritec Products Mfc. Co., Inc. | 06/10/2013Terminated |
| Z-1824-2013 Class II | EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam…Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the… | Steritec Products Mfc. Co., Inc. | 06/10/2013Terminated |
| Z-1823-2013 Class II | Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product…Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the… | Steritec Products Mfc. Co., Inc. | 06/10/2013Terminated |
| Z-1822-2013 Class II | Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product…Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the… | Steritec Products Mfc. Co., Inc. | 06/10/2013Terminated |
| Z-1868-2013 Class II | Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in…Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out… | Mesa Laboratories, Inc., Bozeman… | 06/04/2013Terminated |
| Z-1867-2013 Class II | Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the…Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that… | Mesa Laboratories, Inc., Bozeman… | 06/04/2013Terminated |
| Z-1180-2013 Class II | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological…Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator… | Advanced Sterilization Products | 04/22/2013Terminated |
| Z-0520-2013 Class II | STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with…Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator… | Advanced Sterilization Products | 10/03/2012Terminated |
| Z-2100-2012 Class II | STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as…Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological… | Advanced Sterilization Products | 06/28/2012Terminated |
| Z-1773-2012 | Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24…The recall was initiated by Advanced Sterilization Products because they recently determined that certain… | Advanced Sterilization Products | 02/17/2012Terminated |
| Z-0066-2010 | Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure…Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation… | Advanced Sterilization Products | 06/23/2009Terminated |