FDA Product Code
FDA Product Code FRC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2800
510(k) Clearances — 206 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | 2026-04-08 | Special | PDF ↗ |
| K252680 | Celerity 20 HP Biological Indicator | STERIS Corporation | 2025-09-24 | Special | PDF ↗ |
| K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene | 2025-08-04 | Traditional | PDF ↗ |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Steris | 2025-06-06 | Special | PDF ↗ |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation | 2025-02-06 | Special | PDF ↗ |
| K250061 | Celerity Incubator | STERIS Corporation | 2025-02-06 | Special | PDF ↗ |
| K243501 | 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 | 3M Company | 2025-01-28 | Traditional | PDF ↗ |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | Terragene S.A. | 2024-12-12 | Traditional | PDF ↗ |
| K242538 | 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 | 3M Company | 2024-11-25 | Traditional | PDF ↗ |
| K241959 | 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) | 3M Company | 2024-10-18 | Traditional | PDF ↗ |
| K231383 | 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) | Terragene S.A. | 2024-09-18 | Traditional | PDF ↗ |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | 2024-09-12 | Traditional | PDF ↗ |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2024-06-27 | Special | PDF ↗ |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company | 2024-06-27 | Special | PDF ↗ |
| K233814 | 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) | 3M Company | 2024-03-15 | Traditional | PDF ↗ |
| K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | 2023-12-15 | Special | PDF ↗ |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation | 2023-08-07 | Traditional | PDF ↗ |
| K223715 | Celerity Incubator | STERIS Corporation | 2023-06-15 | Traditional | PDF ↗ |
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | 2023-06-15 | Traditional | PDF ↗ |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2023-05-09 | Traditional | PDF ↗ |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | Terragene S.A. | 2023-02-28 | Traditional | PDF ↗ |
| K213881 | Celerity Incubator | STERIS Corporation | 2022-07-21 | Traditional | PDF ↗ |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | 2022-06-28 | Special | PDF ↗ |
| K213296 | Anprolene SteriTest RRBI | Andersen Sterilizers, Inc. | 2022-04-12 | Traditional | PDF ↗ |
| K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader | 3M Company | 2022-04-06 | Traditional | PDF ↗ |
| K220473 | CELERITY 20 HP Challenge Pack | Steris | 2022-03-18 | Special | PDF ↗ |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2021-10-22 | Traditional | PDF ↗ |
| K203560 | STERIZONE VP4 Test Pack | Tso3 Inc., Now A Part of Stryker | 2021-03-24 | Traditional | PDF ↗ |
| K202879 | EOGas 4 Endo-SteriTest RRBI | Andersen Sterilizers, Inc. | 2021-03-03 | Traditional | PDF ↗ |
| K210277 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | 2021-03-03 | Special | PDF ↗ |
| K202721 | Celerity 20 Steam Biological Indicator for IUSS | STERIS Corporation | 2021-01-08 | Traditional | PDF ↗ |
| K200970 | Self-Contained Biological Indicator | True Indicating, LLC | 2020-12-28 | Traditional | PDF ↗ |
| K200996 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2020-12-11 | Traditional | PDF ↗ |
| K192980 | EOGas 4 Endo-SteriTest | Andersen Sterilizers, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K200766 | 3M Attest Steam Chemical Integrator Test Pack | 3M Company | 2020-07-02 | Traditional | PDF ↗ |
| K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H | 3M Company | 2020-06-05 | Traditional | PDF ↗ |
| K200536 | 3MTM AttestTM Rapid 5 Steam-Plus Test Pack | 3M Complany | 2020-06-01 | Traditional | PDF ↗ |
| K200126 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2020-05-22 | Traditional | PDF ↗ |
| K200092 | 3MTM AttestTM Mini Auto-reader 490M | 3M | 2020-04-15 | Traditional | PDF ↗ |
| K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack | 3M Company | 2020-02-07 | Traditional | PDF ↗ |
| K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | Advanced Sterilization Products (Asp) | 2020-01-23 | Traditional | PDF ↗ |
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Sterilucent, Inc. | 2019-10-22 | Traditional | PDF ↗ |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | Terragene S.A. | 2019-09-13 | Traditional | PDF ↗ |
| K190297 | Celerity HP Incubator | STERIS Corporation | 2019-05-14 | Traditional | PDF ↗ |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | Steris Corporations | 2019-01-03 | Traditional | PDF ↗ |
| K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation | 2019-01-03 | Traditional | PDF ↗ |
| K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | 2018-12-27 | Traditional | PDF ↗ |
| K182931 | 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 | Steris Corporations | 2018-11-20 | Special | PDF ↗ |
| K181434 | SporView Rapid Read Biological Indicator SteamPlus Test Pack | Crosstex/Spsmedical, A Division of Cantel Medical | 2018-11-14 | Traditional | PDF ↗ |
| K181686 | CELERITY 20 Steam Biological Indicator | STERIS Corporation | 2018-07-24 | Special | PDF ↗ |
| K181429 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018-06-13 | Special | PDF ↗ |
| K173519 | 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 | 3M Company | 2018-04-23 | Traditional | PDF ↗ |
| K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H | 3M Company | 2018-03-19 | Traditional | PDF ↗ |
| K173488 | CELERITY 20 HP Challenge Pack | STERIS Corporation | 2018-03-01 | Traditional | PDF ↗ |
| K173633 | 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 | STERIS Corporation | 2018-02-28 | Traditional | PDF ↗ |
| K173626 | Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles | STERIS Corporation | 2018-02-21 | Traditional | PDF ↗ |
| K173629 | CELERITY 20 Steam Process Challenge Device for Gravity Cycles | STERIS Corporation | 2018-02-21 | Traditional | PDF ↗ |
| K173670 | CELERITY 20 Steam Incubator | STERIS Corporation | 2018-02-12 | Traditional | PDF ↗ |
| K173634 | CELERITY 20 Steam Biological Indicator | STERIS Corporation | 2018-02-12 | Traditional | PDF ↗ |
| K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | Steris Corporations | 2018-02-09 | Traditional | PDF ↗ |
| K172752 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018-02-09 | Traditional | PDF ↗ |
| K173435 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2018-02-09 | Traditional | PDF ↗ |
| K171287 | Sporview VH202 BI | Spsmedical Supply Corp. A Division of Cantel Medical | 2018-02-01 | Traditional | PDF ↗ |
| K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader | 3M Company | 2018-01-22 | Traditional | PDF ↗ |
| K172474 | Celerity 20 HP Biological Indicator | STERIS Corporation | 2017-12-29 | Traditional | PDF ↗ |
| K172432 | SporView Rapid Read Biological Indicator | Crosstex/Spsmedical, A Division of Cantel Medical | 2017-12-12 | Traditional | PDF ↗ |
| K163646 | 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 | Terragene S.A. | 2017-11-02 | Traditional | PDF ↗ |
| K170427 | Anprolene SteriTest | Andersen Sterilizers, Inc. | 2017-10-31 | Traditional | PDF ↗ |
| K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017-08-22 | Traditional | PDF ↗ |
| K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017-08-22 | Traditional | PDF ↗ |
| K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader | 3M Company | 2017-07-21 | Traditional | PDF ↗ |
| K170039 | STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) | 2017-06-20 | Traditional | PDF ↗ |
| K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles | STERIS Corporation | 2017-04-28 | Traditional | PDF ↗ |
| K163144 | gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) | Gke-GmbH | 2017-04-07 | Traditional | PDF ↗ |
| K160546 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2016-06-09 | Traditional | PDF ↗ |
| K151482 | BCR-30-min BI and RBIP-ST30 Readout Accessory | Bcr Diagnostics, Inc. | 2016-02-26 | Traditional | PDF ↗ |
| K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015-12-01 | Traditional | PDF ↗ |
| K151585 | Andersen EOGas 4 SteriTest | Andersen Sterilizers, Inc. | 2015-11-18 | Traditional | PDF ↗ |
| K151971 | STERRAD CYCLESURE 24 Biological Indicator | Advanced Sterilization Products | 2015-10-29 | Traditional | PDF ↗ |
| K141580 | STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR | Tso3, Inc. | 2014-12-17 | Traditional | PDF ↗ |
| K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR | Mesa Laboratories, Inc. | 2014-12-03 | Traditional | PDF ↗ |
| K141238 | STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR | Sterilucent, Inc. | 2014-11-03 | Traditional | PDF ↗ |
| K141312 | STERILUCENT PROCESS CHALLENGE DEVICE | Sterilucent, Inc. | 2014-10-31 | Traditional | PDF ↗ |
| K141244 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) | North American Science Assoc., Inc. | 2014-09-09 | Traditional | PDF ↗ |
| K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | Steritec Products Mfg Co, Inc. | 2014-08-27 | Traditional | PDF ↗ |
| K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | Steritec Products Mfg Co, Inc. | 2014-08-25 | Traditional | PDF ↗ |
| K140392 | 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER | 3M Company | 2014-08-13 | Traditional | PDF ↗ |
| K140620 | SPORVIEW PLUS BI TEST PACK | Crosstex International | 2014-08-07 | Traditional | PDF ↗ |
| K140499 | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES | STERIS Corporation | 2014-07-17 | Traditional | PDF ↗ |
| K140708 | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR | STERIS Corporation | 2014-06-16 | Traditional | PDF ↗ |
| K130263 | STERRAD 50/100S/200 TEST PACK | Advanced Sterilization Products | 2014-03-28 | Traditional | PDF ↗ |
| K133267 | DANA REUSABLE TEST PACK | Dana Products, Inc. | 2014-02-11 | Traditional | PDF ↗ |
| K122024 | SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR | Spsmedical Supply Corp. | 2013-11-26 | Traditional | PDF ↗ |
| K122362 | SMART-WELL INCUBATOR | Mesa Laboratories, Inc. | 2013-03-26 | Special | PDF ↗ |
| K123546 | 3M ATTEST(TM) AUTO-READER | 3M Company | 2013-03-18 | Traditional | PDF ↗ |
| K121593 | 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK | 3M Company | 2013-03-15 | Traditional | PDF ↗ |
| K123017 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 | Advanced Sterilization Products | 2012-12-26 | Special | PDF ↗ |
| K121484 | 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER | 3M Company | 2012-10-19 | Traditional | PDF ↗ |
| K122044 | STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2012-10-04 | Special | PDF ↗ |
| K111391 | STERRAD (R) 100NX DUO CYCLE TEST PACK | Advanced Sterilization Products | 2012-09-26 | Traditional | PDF ↗ |
Product code FRC · Class II · General Hospital. Data: openFDA.