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)
Top companies in FRC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2018 | K181429 | CELERITY 20 HP Biological Indicator STERIS Corporation | FRC |
| Apr 23, 2018 | K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-r 3M Company | FRC |
| Mar 19, 2018 | K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H 3M Company | FRC |
| Mar 1, 2018 | K173488 | CELERITY 20 HP Challenge Pack STERIS Corporation | FRC |
| Feb 28, 2018 | K173633 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In- STERIS Corporation | FRC |
| Feb 21, 2018 | K173629 | CELERITY 20 Steam Process Challenge Device for Gravity Cycles STERIS Corporation | FRC |
| Feb 21, 2018 | K173626 | Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation | FRC |
| Feb 12, 2018 | K173670 | CELERITY 20 Steam Incubator STERIS Corporation | FRC |
| Feb 12, 2018 | K173634 | CELERITY 20 Steam Biological Indicator STERIS Corporation | FRC |
| Feb 9, 2018 | K173435 | 3M Attest Rapid Readout Biological Indicator 3M Company | FRC |
| Feb 9, 2018 | K172752 | CELERITY 20 HP Biological Indicator STERIS Corporation | FRC |
| Feb 9, 2018 | K172748 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack Steris Corporations | FRC |
| Feb 1, 2018 | K171287 | Sporview VH202 BI Spsmedical Supply Corp. A Division of Cantel Medical | FRC |
| Jan 22, 2018 | K173584 | 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader 3M Company | FRC |
| Dec 29, 2017 | K172474 | Celerity 20 HP Biological Indicator STERIS Corporation | FRC |
| Dec 12, 2017 | K172432 | SporView Rapid Read Biological Indicator Crosstex/Spsmedical, A Division of Cantel Medical | FRC |
| Nov 2, 2017 | K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222- Terragene S.A., AR | FRC |
| Oct 31, 2017 | K170427 | Anprolene SteriTest Andersen Sterilizers, Inc. | FRC |
| Aug 22, 2017 | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator STERIS Corporation | FRC |
| Aug 22, 2017 | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator STERIS Corporation | FRC |
| Jul 21, 2017 | K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader 3M Company | FRC |
| Jun 20, 2017 | K170039 | STERRAD VELOCITY Biological Indictator and Reader Advanced Sterilization Products (Asp) | FRC |
| Apr 28, 2017 | K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles STERIS Corporation | FRC |
| Apr 7, 2017 | K163144 | gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) Gke-GmbH, DE | FRC |
| Jun 9, 2016 | K160546 | 3M Attest Rapid Readout Biological Indicator 3M Company | FRC |
| Feb 26, 2016 | K151482 | BCR-30-min BI and RBIP-ST30 Readout Accessory Bcr Diagnostics, Inc. | FRC |
| Dec 1, 2015 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 3M Company | FRC |
| Nov 18, 2015 | K151585 | Andersen EOGas 4 SteriTest Andersen Sterilizers, Inc. | FRC |
| Oct 29, 2015 | K151971 | STERRAD CYCLESURE 24 Biological Indicator Advanced Sterilization Products | FRC |
| Dec 17, 2014 | K141580 | STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR Tso3, Inc. | FRC |
| Dec 3, 2014 | K140589 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR Mesa Laboratories, Inc. | FRC |
| Nov 3, 2014 | K141238 | STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR Sterilucent, Inc. | FRC |
| Oct 31, 2014 | K141312 | STERILUCENT PROCESS CHALLENGE DEVICE Sterilucent, Inc. | FRC |
| Sep 9, 2014 | K141244 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) North American Science Assoc., Inc. | FRC |
| Aug 27, 2014 | K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc. | FRC |
| Aug 25, 2014 | K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc. | FRC |
| Aug 13, 2014 | K140392 | 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER 3M Company | FRC |
| Aug 7, 2014 | K140620 | SPORVIEW PLUS BI TEST PACK Crosstex International | FRC |
| Jul 17, 2014 | K140499 | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES STERIS Corporation | FRC |
| Jun 16, 2014 | K140708 | VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR STERIS Corporation | FRC |
| Mar 28, 2014 | K130263 | STERRAD 50/100S/200 TEST PACK Advanced Sterilization Products | FRC |
| Feb 11, 2014 | K133267 | DANA REUSABLE TEST PACK Dana Products, Inc. | FRC |
| Nov 26, 2013 | K122024 | SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR Spsmedical Supply Corp. | FRC |
| Mar 26, 2013 | K122362 | SMART-WELL INCUBATOR Mesa Laboratories, Inc. | FRC |
| Mar 18, 2013 | K123546 | 3M ATTEST(TM) AUTO-READER 3M Company | FRC |
| Mar 15, 2013 | K121593 | 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK 3M Company | FRC |
| Dec 26, 2012 | K123017 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 Advanced Sterilization Products | FRC |
| Oct 19, 2012 | K121484 | 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER 3M Company | FRC |
| Oct 4, 2012 | K122044 | STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Sep 26, 2012 | K111391 | STERRAD (R) 100NX DUO CYCLE TEST PACK Advanced Sterilization Products | FRC |
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