| Celerity 5 HP Biological Indicator (LCB052) (K260766) | STERIS Corporation | 2026-04-08 |
| Celerity™ 20 HP Biological Indicator (K252680) | STERIS Corporation | 2025-09-24 |
| Terragene® Bionova® BT20 Biological Indicator (K251122) | Terragene | 2025-08-04 |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K251452) | Steris | 2025-06-06 |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K250044) | STERIS Corporation | 2025-02-06 |
| Celerity Incubator (K250061) | STERIS Corporation | 2025-02-06 |
| 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K243501) | 3M Company | 2025-01-28 |
| Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) (K242453) | Terragene S.A. | 2024-12-12 |
| 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K242538) | 3M Company | 2024-11-25 |
| 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (K241959) | 3M Company | 2024-10-18 |
| Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K231383) | Terragene S.A. | 2024-09-18 |
| 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M (K241710) | 3M Company | 2024-09-12 |
| 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) (K241542) | 3M Company | 2024-06-27 |
| 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K240717) | 3M Company | 2024-06-27 |
| 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (K233814) | 3M Company | 2024-03-15 |
| ConFirm 20 Minute Incubator (K233681) | STERIS Corporation | 2023-12-15 |
| Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator (K231490) | STERIS Corporation | 2023-08-07 |
| Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack (K223717) | STERIS Corporation | 2023-06-15 |
| Celerity Incubator (K223715) | STERIS Corporation | 2023-06-15 |
| Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K223023) | Plasmapp Co,., Ltd. | 2023-05-09 |
| Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) (K221641) | Terragene S.A. | 2023-02-28 |
| Celerity Incubator (K213881) | STERIS Corporation | 2022-07-21 |
| 3M Attest Rapid Readout Biological Indicator, 1295 (K211705) | 3M Company | 2022-06-28 |
| Anprolene SteriTest RRBI (K213296) | Andersen Sterilizers, Inc. | 2022-04-12 |
| 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader (K213809) | 3M Company | 2022-04-06 |
| CELERITY 20 HP Challenge Pack (K220473) | Steris | 2022-03-18 |
| Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K212193) | Plasmapp Co,., Ltd. | 2021-10-22 |
| STERIZONE VP4 Test Pack (K203560) | Tso3 Inc., Now A Part of Stryker | 2021-03-24 |
| 3M Attest Rapid Readout Biological Indicator, 1295 (K210277) | 3M Company | 2021-03-03 |
| EOGas 4 Endo-SteriTest RRBI (K202879) | Andersen Sterilizers, Inc. | 2021-03-03 |
| Celerity 20 Steam Biological Indicator for IUSS (K202721) | STERIS Corporation | 2021-01-08 |
| Self-Contained Biological Indicator (K200970) | True Indicating, LLC | 2020-12-28 |
| 3M Attest Rapid Readout Biological Indicator (K200996) | 3M Company | 2020-12-11 |
| EOGas 4 Endo-SteriTest (K192980) | Andersen Sterilizers, Inc. | 2020-11-12 |
| 3M Attest Steam Chemical Integrator Test Pack (K200766) | 3M Company | 2020-07-02 |
| 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H (K192550) | 3M Company | 2020-06-05 |
| 3MTM AttestTM Rapid 5 Steam-Plus Test Pack (K200536) | 3M Complany | 2020-06-01 |
| VERIFY Assert Self-Contained Biological Indicator (K200126) | STERIS Corporation | 2020-05-22 |
| 3MTM AttestTM Mini Auto-reader 490M (K200092) | 3M | 2020-04-15 |
| 3M Attest Super Rapid 5 Steam-Plus Challenge Pack (K193154) | 3M Company | 2020-02-07 |
| STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader (K192025) | Advanced Sterilization Products (Asp) | 2020-01-23 |
| Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (K192001) | Sterilucent, Inc. | 2019-10-22 |
| Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye (K191021) | Terragene S.A. | 2019-09-13 |
| Celerity HP Incubator (K190297) | STERIS Corporation | 2019-05-14 |
| CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack (K183294) | STERIS Corporation | 2019-01-03 |
| VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K183300) | Steris Corporations | 2019-01-03 |
| STERRAD VELOCITY Biological Indicator (K182404) | Advanced Sterilization Products (Asp) | 2018-12-27 |
| VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K182931) | Steris Corporations | 2018-11-20 |
| SporView Rapid Read Biological Indicator SteamPlus Test Pack (K181434) | Crosstex/Spsmedical, A Division of Cantel Medical | 2018-11-14 |
| CELERITY 20 Steam Biological Indicator (K181686) | STERIS Corporation | 2018-07-24 |
| CELERITY 20 HP Biological Indicator (K181429) | STERIS Corporation | 2018-06-13 |
| 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader (K173519) | 3M Company | 2018-04-23 |
| 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H (K173437) | 3M Company | 2018-03-19 |
| CELERITY 20 HP Challenge Pack (K173488) | STERIS Corporation | 2018-03-01 |
| VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (K173633) | STERIS Corporation | 2018-02-28 |
| CELERITY 20 Steam Process Challenge Device for Gravity Cycles (K173629) | STERIS Corporation | 2018-02-21 |
| Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (K173626) | STERIS Corporation | 2018-02-21 |
| CELERITY 20 Steam Biological Indicator (K173634) | STERIS Corporation | 2018-02-12 |
| CELERITY 20 Steam Incubator (K173670) | STERIS Corporation | 2018-02-12 |
| CELERITY 20 HP Biological Indicator (K172752) | STERIS Corporation | 2018-02-09 |
| 3M Attest Rapid Readout Biological Indicator (K173435) | 3M Company | 2018-02-09 |
| VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack (K172748) | Steris Corporations | 2018-02-09 |
| Sporview VH202 BI (K171287) | Spsmedical Supply Corp. A Division of Cantel Medical | 2018-02-01 |
| 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader (K173584) | 3M Company | 2018-01-22 |
| Celerity 20 HP Biological Indicator (K172474) | STERIS Corporation | 2017-12-29 |
| SporView Rapid Read Biological Indicator (K172432) | Crosstex/Spsmedical, A Division of Cantel Medical | 2017-12-12 |
| Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator (K163646) | Terragene S.A. | 2017-11-02 |
| Anprolene SteriTest (K170427) | Andersen Sterilizers, Inc. | 2017-10-31 |
| VERIFY Assert VH2O2 Self-Contained Biological Indicator (K171504) | STERIS Corporation | 2017-08-22 |
| VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator (K171587) | STERIS Corporation | 2017-08-22 |
| 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (K171003) | 3M Company | 2017-07-21 |
| STERRAD VELOCITY Biological Indictator and Reader (K170039) | Advanced Sterilization Products (Asp) | 2017-06-20 |
| VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles (K170070) | STERIS Corporation | 2017-04-28 |
| gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) (K163144) | Gke-GmbH | 2017-04-07 |
| 3M Attest Rapid Readout Biological Indicator (K160546) | 3M Company | 2016-06-09 |
| BCR-30-min BI™ and RBIP-ST30™ Readout Accessory (K151482) | Bcr Diagnostics, Inc. | 2016-02-26 |
| 3M Attest Rapid Readout Biological Indicator 1295 (K152060) | 3M Company | 2015-12-01 |
| Andersen EOGas 4 SteriTest (K151585) | Andersen Sterilizers, Inc. | 2015-11-18 |
| STERRAD CYCLESURE 24 Biological Indicator (K151971) | Advanced Sterilization Products | 2015-10-29 |
| STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (K141580) | Tso3, Inc. | 2014-12-17 |
| STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (K140589) | Mesa Laboratories, Inc. | 2014-12-03 |
| STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR (K141238) | Sterilucent, Inc. | 2014-11-03 |
| STERILUCENT PROCESS CHALLENGE DEVICE (K141312) | Sterilucent, Inc. | 2014-10-31 |
| NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) (K141244) | North American Science Assoc., Inc. | 2014-09-09 |
| STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K133549) | Steritec Products Mfg Co, Inc. | 2014-08-27 |
| STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K133322) | Steritec Products Mfg Co, Inc. | 2014-08-25 |
| 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER (K140392) | 3M Company | 2014-08-13 |
| SPORVIEW PLUS BI TEST PACK (K140620) | Crosstex International | 2014-08-07 |
| VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES (K140499) | STERIS Corporation | 2014-07-17 |
| VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR (K140708) | STERIS Corporation | 2014-06-16 |
| STERRAD 50/100S/200 TEST PACK (K130263) | Advanced Sterilization Products | 2014-03-28 |
| DANA REUSABLE TEST PACK (K133267) | Dana Products, Inc. | 2014-02-11 |
| SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR (K122024) | Spsmedical Supply Corp. | 2013-11-26 |
| SMART-WELL INCUBATOR (K122362) | Mesa Laboratories, Inc. | 2013-03-26 |
| 3M ATTEST(TM) AUTO-READER (K123546) | 3M Company | 2013-03-18 |
| 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK (K121593) | 3M Company | 2013-03-15 |
| STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 (K123017) | Advanced Sterilization Products | 2012-12-26 |
| 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER (K121484) | 3M Company | 2012-10-19 |
| STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR (K122044) | Advanced Sterilization Products | 2012-10-04 |
| STERRAD (R) 100NX DUO CYCLE TEST PACK (K111391) | Advanced Sterilization Products | 2012-09-26 |