Indicator, Physical/Chemical Sterilization Process
FDA product code JOJ · Class II (moderate risk) · 21 CFR 880.2800 · General Hospital
264510(k) clearances
0PMA approvals
18recalls
Manufacturers
- STERIS Corporation 42
- 3M Company 24
- Spsmedical Supply Corp. 17
- Steritec Products Mfg Co, Inc. 16
- Albert Browne , Ltd. 16
- Steritec Products, Inc. 12
- Serim Research Corp. 12
- Propper Mfg. Co., Inc. 11
- Advanced Sterilization Products 8
- Dana Products, Inc. 6
- Andersen Sterilizers, Inc. 5
- Pymah Corp. 5
- Propper Manufacturing Co., Inc. 5
- Board of Directors, Albert Browne , Ltd. 5
- American Sterilizer Co. 4
- Kem Medical Products Corp. 3
- True Indicating, LLC 3
- Castle Co. 3
- North American Science Assoc., Inc. 2
- Amsco Co. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam SterilizationJOJ · Special | Intertape Polymer Group | 02/20/2026SE |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…JOJ · Traditional | Shenzhen Safesecure Medical Infection Control… | 12/23/2025SE |
| K251035 | DISINTEK PA Test StripsJOJ · Traditional | Serim Research | 06/03/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | STERIS Corporation | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | STERIS Corporation | 04/25/2025SE |
| K250172 | Green Card Bowie-Dick Test (BD115)JOJ · Special | Steritec Products, Inc. (A Getinge Company) | 02/20/2025SE |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15)JOJ · Traditional | True Indicating, LLC | 01/17/2025SE |
| K241036 | Autoclave Indicator Tape; EO Indicator TapeJOJ · Traditional | Jiangmen New Era External Use Drug Co., Ltd. | 12/17/2024SE |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015)JOJ · Special | STERIS Corporation | 12/04/2024SE |
| K242795 | Getinge Assured MI Steam Migrating IntegratorJOJ · Special | Steritec Products Mfg. (A Getinge Group Company) | 10/15/2024SE |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam SterilizationJOJ · Traditional | Kem Medical Products Corporation | 09/30/2024SE |
| K242189 | CELERITY HP Indicator Tape (PCC077)JOJ · Special | Steris | 08/20/2024SE |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…JOJ · Traditional | Advanced Sterilization Products, Inc. | 07/05/2024SE |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B)JOJ · Traditional | True Indicating, LLC | 06/26/2024SE |
| K240910 | EO Chex Indicator TapeJOJ · Abbreviated | Propper Manufacturing Co., Inc. | 06/12/2024SE |
| K241344 | MetriCide OPA Plus Solution Test StripJOJ · Special | Steris | 06/11/2024SE |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPSJOJ · Traditional | STERIS Corporation | 04/17/2024SE |
| K240760 | CELERITY HP Indicator TapeJOJ · Special | Steris | 04/10/2024SE |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…JOJ · Special | Steris | 12/08/2023SE |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)JOJ · Special | Steris | 10/27/2023SE |
| K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY…JOJ · Traditional | Steris | 08/07/2023SE |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical IndicatorJOJ · Traditional | STERIS Corporation | 07/17/2023SE |
| K222137 | OK Plus IndicatorJOJ · Abbreviated | Propper Manufacturing Co., Inc. | 12/05/2022SE |
| K220778 | Chemical Indicator for SteamJOJ · Traditional | True Indicating, LLC | 12/02/2022SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 3M Company | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 3M Company | 09/23/2022SE |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)JOJ · Special | 3M Company | 06/24/2022SE |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape…JOJ · Traditional | 3M Company | 05/23/2022SE |
| K213412 | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMJOJ · Traditional | Steris Corparation | 01/21/2022SE |
| K212592 | Gas-Chex IndicatorJOJ · Abbreviated | Propper Manufacturing Co., Inc. | 01/20/2022SE |
| K212081 | 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228JOJ · Special | 3M Company | 09/05/2021SE |
| K200096 | Crosstex VH2O2 Chemical IndicatorsJOJ · Special | Crosstex International, Inc. (A Cantel Medical… | 07/15/2021SE |
| K210866 | Steri-Dot Process IndicatorJOJ · Abbreviated | Propper Manufacturing Co., Inc. | 06/21/2021SE |
| K210553 | Steam-Dot Process IndicatorJOJ · Abbreviated | Propper Manufacturing Co., Inc. | 05/19/2021SE |
| K203458 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Special | 3M Company | 12/11/2020SE |
| K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228JOJ · Special | 3M Company | 12/10/2020SE |
| K202565 | WAVICIDE-OPA MEC IndicatorJOJ · Traditional | Serim Research Corporation | 12/02/2020SE |
| K200334 | AN1036 DosimeterJOJ · Traditional | Andersen Sterilizers, Inc. | 11/12/2020SE |
| K200272 | Terragene ChemdyeJOJ · Traditional | Terragene S.A. | 06/30/2020SE |
| K200252 | Getinge Assured MI Steam Migrating IntegratorJOJ · Traditional | Steritec Products Mfg Co, Inc. | 05/21/2020SE |
| K192445 | QwikCheck Chemical IndicatorsJOJ · Traditional | Serim Research Corporation | 04/02/2020SE |
| K193254 | 3M Attest Steam Chemical IntegratorJOJ · Special | 3M Company | 12/23/2019SE |
| K191236 | 3M Attest Steam Chemical IntegratorsJOJ · Traditional | 3M Company | 11/22/2019SE |
| K192937 | 3M Comply Hydrogen Peroxide Chemical IndicatorJOJ · Special | 3M Company | 11/16/2019SE |
| K192673 | 3M Comply Hydrogen Peroxide Indicator Tape 1228JOJ · Special | 3M Company | 10/28/2019SE |
| K191999 | Sterilucent VH2O2 Chemical IndicatorsJOJ · Traditional | Sterilucent, Inc. | 10/21/2019SE |
| K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive…JOJ · Special | STERIS Corporation | 09/05/2019SE |
| K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeJOJ · Special | Intertape Polymer, Inc. | 08/02/2019SE |
| K181788 | Lead-free Chemical Indicators for Steam SterilizationJOJ · Traditional | Kem Medical Products Corp. | 03/01/2019SE |
| K183211 | 3M Comply Hydrogen Peroxide Chemical IndicatorJOJ · Traditional | 3M Company | 02/26/2019SE |
| K183209 | 3M Comply Hydrogen Peroxide Indicator TapeJOJ · Traditional | 3M Company | 02/15/2019SE |
| K183295 | Celerity HP Chemical Indicator (CI)JOJ · Abbreviated | Steris Corporations | 01/04/2019SE |
| K183293 | VERIFY VH202 Indicator TapeJOJ · Traditional | STERIS Corporation | 01/04/2019SE |
| K182724 | CelerityTM 10 STEAM Chemical IndicatorJOJ · Traditional | STERIS Corporation | 12/10/2018SE |
| K173428 | VERIFY Chemical Indicator for S40 SterilantJOJ · Traditional | STERIS Corporation | 03/02/2018SE |
| K171823 | U&U Indicator tape and stripJOJ · Traditional | U&U Medical Technology Co, Ltd. | 02/22/2018SE |
| K172753 | VERIFY VH2O2 Indicator TapeJOJ · Traditional | STERIS Corporation | 02/09/2018SE |
| K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive…JOJ · Abbreviated | STERIS Corporation | 02/09/2018SE |
| K172472 | Micro-MEC 1.8% Glutaraldehyde Monitor StripJOJ · Traditional | STERIS Corporation | 11/17/2017SE |
| K170439 | AN87 DosimeterJOJ · Traditional | Andersen Sterilizers, Inc. | 11/01/2017SE |
| K170426 | AN85/AN86 EO IndicatorsJOJ · Traditional | Andersen Sterilizers, Inc. | 10/30/2017SE |
| K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 3M Company | 08/14/2017SE |
| K170563 | 3M Comply Hydrogen Peroxide Indicator TapeJOJ · Traditional | 3M Company | 07/27/2017SE |
| K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…JOJ · Traditional | STERIS Corporation | 03/21/2017SE |
| K162631 | VERIFY STEAM Integrating Indicator - ShortJOJ · Traditional | STERIS Corporation | 01/27/2017SE |
| K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeJOJ · Special | Canadian Technical Tape, Ltd. | 06/28/2016SE |
| K160485 | VERIFY VH2O2 Indicator TapeJOJ · Traditional | STERIS Corporation | 06/01/2016SE |
| K152630 | VERIFY STEAM Integrating IndicatorJOJ · Traditional | STERIS Corporation | 05/12/2016SE |
| K152394 | Rapicide PA High-Level Disinfectant Test StripsJOJ · Traditional | Medivators, Inc. | 03/11/2016SE |
| K150645 | AN1087 DosimeterJOJ · Traditional | Andersen Sterilizers, Inc. | 11/19/2015SE |
| K150644 | AN85/AN86 EO IndicatorsJOJ · Traditional | Andersen Sterilizers, Inc. | 11/18/2015SE |
| K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 3M Company | 10/01/2015SE |
| K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 3M Company | 09/29/2015SE |
| K150477 | 3M Comply Indicator Tape for Ethylene Oxide (EO) SterilizationJOJ · Traditional | 3M Company | 07/02/2015SE |
| K143520 | SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External…JOJ · Traditional | Crosstex | 06/09/2015SE |
| K143629 | U&U Bowie-Dick Test PackJOJ · Traditional | U&U Medical Technology Co, Ltd. | 05/19/2015SE |
| K143333 | Revital-Ox RESERT Solution Test StripJOJ · Traditional | STERIS Corporation | 04/14/2015SE |
| K141698 | Sterizone Chemical IndicatorJOJ · Traditional | Tso3, Inc. | 12/17/2014SE |
| K140566 | Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeJOJ · Traditional | Crosstex International | 11/24/2014SE |
| K140940 | Process Indicator Tape for Steam SterilizationJOJ · Traditional | Canadian Technical Tape, Ltd. | 10/27/2014SE |
| K140515 | Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator Adhesive LabelJOJ · Abbreviated | STERIS Corporation | 07/17/2014SE |
| K132291 | Namsa Chemical ProcessJOJ · Traditional | North American Science Assoc., Inc. | 05/20/2014SE |
| K133204 | Airview Mini Owie Dick Test PackJOJ · Traditional | Crosstex International | 05/05/2014SE |
| K132372 | Steritec Green Card Pack Bowie-Dick TestJOJ · Traditional | Steritec Products Mfg Co, Inc. | 11/26/2013SE |
| K130135 | Dana Reusable Bi Test PackJOJ · Traditional | Dana Products, Inc. | 11/25/2013SE |
| K130160 | Verify Process Indicator for Reliance EpsJOJ · Traditional | STERIS Corporation | 08/16/2013SE |
| K130211 | Airview Bowie Dick; Test Pack, Indicator SheetsJOJ · Special | Spsmedical Supply Corp. | 07/05/2013SE |
| K122945 | Steritec Green Card Pack Bowie-Dick Test Model BD 126JOJ · Abbreviated | Steritec Products Mfg Co, Inc. | 04/30/2013SE |
| K120592 | Dana Reusable Bowie Test Pack for Dana Bowie Dick IndicatorsJOJ · Traditional | Dana Products, Inc. | 02/27/2013SE |
| K122555 | Steritec Lead Free Sterilization Process Indicator TapeJOJ · Abbreviated | Steritec Products Mfg Co, Inc. | 12/12/2012SE |
| K120652 | Rapicide OPA-28 Test StripJOJ · Traditional | Serim Research Corp. | 10/12/2012SE |
| K111519 | Sterrad Sealsure Chemical Indicator Tape Model 14202JOJ · Traditional | Advanced Sterilization Products | 10/03/2012SE |
| K111518 | Sterrad Chemial Indicator Strip Model 14100JOJ · Traditional | Advanced Sterilization Products | 10/03/2012SE |
| K120435 | Browne Aldahol Glutaraldehyde IndicatorJOJ · Traditional | STERIS Corporation | 06/04/2012SE |
| K111453 | Steam Dot Blu Process IndicatorJOJ · Abbreviated | Propper Mfg. Co., Inc. | 04/05/2012SE |
| K112256 | Steris Steam PiJOJ · Abbreviated | STERIS Corporation | 01/11/2012SE |
| K103331 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization ProcessesJOJ · Traditional | STERIS Corporation | 09/01/2011SE |
| K102894 | Classix Chemical Sterilization IndicatorJOJ · Abbreviated | Propper Mfg. Co., Inc. | 05/25/2011SE |
| K110369 | Indistrip GreenJOJ · Traditional | Indilab, Inc. | 05/06/2011SE |
| K110253 | Reusable Test Pack for Dana Emulating IndicatorsJOJ · Traditional | Dana Products, Inc. | 04/29/2011SE |
| K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | Spsmedical Supply Corp. | 04/15/2011SE |
| K103219 | Sterrad Sealsure Chemical Indicator TapeJOJ · Traditional | Advanced Sterilization Products | 04/01/2011SE |
| K103218 | Sterrad Chemical Indicator StripJOJ · Traditional | Advanced Sterilization Products | 04/01/2011SE |
| K103053 | Verify 270FP Challenge PackJOJ · Abbreviated | STERIS Corporation | 03/10/2011SE |
| K103126 | Trophon Chemical IndicatorJOJ · Traditional | Nanosonics Limited | 03/03/2011SE |
| K103000 | Smart Read Biological Test PackJOJ · Special | Steritec Products Mfg Co, Inc. | 02/11/2011SE |
| K102296 | Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2)JOJ · Traditional | STERIS Corporation | 02/09/2011SE |
| K102363 | Spsmedical Emplus 270 F Steam Emulator Model EMP-104, EMP-1004JOJ · Traditional | Spsmedical Supply Corp. | 01/27/2011SE |
| K100891 | Dana Emulating IndicatorJOJ · Traditional | Dana Products, Inc. | 01/13/2011SE |
| K102761 | Dana Reusable Test Pack for Steam SterilizationJOJ · Traditional | Dana Products, Inc. | 12/20/2010SE |
| K102217 | System 1E Chemical IndicatorJOJ · Traditional | STERIS Corporation | 11/22/2010SE |
| K101528 | 3M Comply Lead Free Process Indicators for SteamJOJ · Traditional | 3M Company | 10/01/2010SE |
| K101249 | Sterigage Model 1243RA, 1243RB, 1243REJOJ · Traditional | 3M Company | 09/08/2010SE |
| K101580 | Nev's Ink Autoclave TapesJOJ · Traditional | Nev'S Ink, Inc. | 07/01/2010SE |
| K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171JOJ · Traditional | Serim Research Corp. | 01/07/2010SE |
| K093199 | 3M Comply Bowie- Dick Type Lead Free Test PackJOJ · Special | 3M Company | 12/04/2009SE |
| K091174 | Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version…JOJ · Abbreviated | STERIS Corporation | 10/27/2009SE |
| K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | Spsmedical Supply Corp. | 10/09/2009SE |
| K083643 | Verify 275F Gravity IndicatorsJOJ · Abbreviated | STERIS Corporation | 08/07/2009SE |
| K082620 | Once-A-Day Vertos Test PackJOJ · Abbreviated | Propper Mfg. Co., Inc. | 07/08/2009SE |
| K083295 | Serim Disintek Gta 2.1%, Model: 5164JOJ · Traditional | Serim Research Corp. | 03/16/2009SE |
| K083650 | Emu-Graph 4 Emulator, Model Ci 144JOJ · Special | Steritec Products, Inc. | 03/05/2009SE |
| K082352 | Serim Disintek Opa Test StripJOJ · Traditional | Serim Research Corp. | 09/25/2008SE |
| K081600 | Steris Resert XL Test StripJOJ · Traditional | STERIS Corporation | 08/22/2008SE |
| K080136 | Instant Readout Chemical Integrator Challenge Pack, Model Lt- 105JOJ · Traditional | Steritec Products, Inc. | 08/15/2008SE |
| K081370 | Serim Disintek Opa Test StripJOJ · Traditional | Serim Research Corp. | 07/11/2008SE |
| K081427 | Browne Opa Test StripJOJ · Special | STERIS Corporation | 06/11/2008SE |
| K080750 | Browne Rapicide Glutaraldehyde IndicatorJOJ · Traditional | STERIS Corporation | 05/12/2008SE |
| K080307 | Prochem Indicator TapeJOJ · Traditional | Raven Laboratories | 05/01/2008SE |
| K072408 | Emu-Graph Emulator, Model Ci 131JOJ · Traditional | Steritec Products Mfg Co, Inc. | 04/30/2008SE |
| K073683 | Verify Challenge Packs - Version 2JOJ · Special | STERIS Corporation | 01/25/2008SE |
| K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2JOJ · Abbreviated | STERIS Corporation | 12/11/2007SE |
| K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorJOJ · Abbreviated | STERIS Corporation | 11/14/2007SE |
| K070895 | Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10…JOJ · Abbreviated | STERIS Corporation | 09/05/2007SE |
| K070419 | Opaciden Opa Reagent StripsJOJ · Traditional | Hach Company | 08/31/2007SE |
| K070461 | Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4JOJ · Abbreviated | STERIS Corporation | 07/17/2007SE |
| K062651 | Prochem Ext Chemical IntegratorJOJ · Traditional | Raven Biological Laboratories, Inc. | 03/15/2007SE |
| K063285 | Reliance Ci Process IndicatorJOJ · Traditional | Albert Browne , Ltd. | 01/12/2007SE |
| K063799 | Steamplus Steam IntegratorJOJ · Traditional | Spsmedical Supply Corp. | 01/05/2007SE |
| K061738 | Albert Browne Ltd. Verify Steam and Eo Load Record CardJOJ · Traditional | Albert Browne , Ltd. | 08/25/2006SE |
| K053479 | Verify Dry Heat LabelJOJ · Traditional | Albert Browne , Ltd. | 07/18/2006SE |
| K060066 | Verify 3-10 Min Flash IntegratorJOJ · Traditional | Albert Browne , Ltd. | 03/24/2006SE |
| K060103 | Albert Browne Ltd. Verify Steam Value IndicatorsJOJ · Special | Albert Browne , Ltd. | 03/07/2006SE |
| K051101 | Verify Flash IntegratorJOJ · Traditional | Albert Browne , Ltd. | 12/06/2005SE |
| K052388 | Serim Peracetic Acid Chemical IndicatorJOJ · Traditional | Serim Research Corp. | 12/01/2005SE |
| K052516 | Steritec Container Cord - Ci 135, Steritec Process Indicator Labels - Ci 140, Steritec…JOJ · Abbreviated | Steritec Products, Inc. | 10/03/2005SE |
| K043482 | The Reliance Pi Process Indicator, Model D5116JOJ · Traditional | STERIS Corporation | 12/21/2004SE |
| K040901 | Steritec Emu-Graph, Model No. Ci 131/USJOJ · Traditional | Steritec Products, Inc. | 09/09/2004SE |
| K031152 | Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)JOJ · Traditional | Propper Mfg. Co., Inc. | 08/17/2004SE |
| K041017 | Spsmedical Airview Bowie Dick Test PackJOJ · Traditional | Spsmedical Supply Corp. | 06/25/2004SE |
| K040742 | Modification to Sterrad Sealsure Chemical Indicator TapeJOJ · Special | Advanced Sterilization Products | 04/02/2004SE |
| K032801 | Modified Browne Packaging and Label Steam Process IndicatorJOJ · Special | Albert Browne , Ltd. | 10/17/2003SE |
| K021161 | TSO3 Ozone Chemical IndicatorJOJ · Traditional | Technologies of Sterilization With Oxone, Tso3… | 08/27/2003SE |
| K024293 | Bowie-Dick Mini Pak, Model BD 115JOJ · Abbreviated | Steritec Products, Inc. | 08/11/2003SE |
| K031647 | Biosign Ssi Biological Test Pack with Instant Readout IntegratorJOJ · Traditional | Getinge USA, Inc. | 07/29/2003SE |
| K030680 | Spsmedical Gas Plasma Chemical IndicatorJOJ · Traditional | Spsmedical Supply Corp. | 05/09/2003SE |
| K022441 | Sterrad Sealsure Chemical Indicator TapeJOJ · Traditional | Advanced Sterilization Products | 10/08/2002SE |
| K020409 | Steamplus Sterilization TestJOJ · Traditional | Spsmedical Supply Corp. | 07/18/2002SE |
| K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackJOJ · Traditional | Albert Browne , Ltd. | 07/03/2002SE |
| K020612 | Sultan Sporox Test Vial, Model 75195JOJ · Traditional | Sultan Chemists, Inc. | 05/07/2002SE |
| K012195 | Steam Sterilization IntergratorJOJ · Traditional | Dana Products, Inc. | 05/07/2002SE |
| K020589 | 3M Comply 1228 Gas Plasma Indicator TapeJOJ · Traditional | 3M Company | 04/22/2002SE |
| K012732 | Integraph Flash, Model Ci 110JOJ · Traditional | Steritec Products, Inc. | 03/04/2002SE |
| K013228 | 3M Comply 1248 Gas Plasma Chemical IndicatorJOJ · Traditional | Minnesota Mining and Mfg. Co. | 01/18/2002SE |
| K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…JOJ · Traditional | Albert Browne , Ltd. | 10/01/2001SE |
| K010534 | Cross-Checks Dual, Model Ci 125JOJ · Traditional | Steritec Products, Inc. | 08/06/2001SE |
| K003533 | Cross-Checks LF, Model Ci 119/S &Ci 119/LJOJ · Abbreviated | Steritec Products, Inc. | 02/07/2001SE |
| K003002 | Sterilization Process Indicator Tapes Model CI112 & CI123JOJ · Traditional | Steritec Products, Inc. | 12/08/2000SE |
| K002861 | Eo Gas Sterilization Process Indicator Tapes, Model Ci 124JOJ · Abbreviated | Steritec Products, Inc. | 11/29/2000SE |
| K000355 | 3M Comply 1249 Liquid Peracetic Acid Chemical IndicatorJOJ · Traditional | Minnesota Mining and Mfg. Co. | 08/23/2000SE |
| K001649 | Steritec Autoclave Tapes, Model CI122 & CI1234JOJ · Abbreviated | Steritec Products, Inc. | 06/23/2000SE |
| K001444 | Steritec Steam Biological Test Pack with Instant Readout Integrator, Model Bi 103JOJ · Special | Steritec Products, Inc. | 05/15/2000SE |
| K000502 | Steam/Eo Record Card, Model Ci 121JOJ · Special | Steritec Products Mfg Co, Inc. | 03/14/2000SE |
| K992767 | Browne Packaging and Label Steam Process IndicatorJOJ · Abbreviated | Albert Browne , Ltd. | 01/10/2000SE |
| K992341 | Cidex Opa Solution Test StripJOJ · Traditional | Serim Research Corp. | 11/23/1999SE |
| K991709 | Browne Cidex Opa IndicatorJOJ · Traditional | Albert Browne , Ltd. | 10/08/1999SE |
| K991276 | Pass/Fail Challenge PackJOJ · Traditional | Propper Mfg. Co., Inc. | 07/12/1999SE |
| K991418 | Browne Mvi Ethylene Oxide IndicatorJOJ · Abbreviated | Albert Browne , Ltd. | 06/10/1999SE |
| K990246 | Steri-Pak LF Bowie-Dick Test PackJOJ · Traditional | Steritec Products Mfg Co, Inc. | 06/10/1999SE |
| K983451 | Challenge Test PackJOJ · Traditional | North American Science Assoc., Inc. | 04/23/1999SE |
| K982151 | Steritite Process Indicator AccessoriesJOJ · Traditional | Case Medical, Inc. | 02/09/1999SE |
| K984616 | Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting…JOJ · Traditional | Albert Browne , Ltd. | 02/04/1999SE |
| K984613 | Browne Sporicidin Phenol Indicator for Sporicidin Sterilizing and Disinfecting SolutionJOJ · Traditional | Albert Browne , Ltd. | 02/04/1999SE |
| K981054 | Browne Ga Indicator for Cidex ProductsJOJ · Traditional | Albert Browne , Ltd. | 12/07/1998SE |
| K982188 | Steri-Pak Bowie Dick Test PackJOJ · Traditional | Steritec Products Mfg Co, Inc. | 11/20/1998SE |
| K973585 | Propper Eo Line Ethylene Oxide Sterilization IntegratorJOJ · Traditional | Propper Mfg. Co., Inc. | 11/06/1998SE |
| K982547 | Steritec Cross-Checks Eo Gas Sterilization IntegratorJOJ · Traditional | Steritec Products Mfg Co, Inc. | 10/08/1998SE |
| K974415 | Kimberly-Clark Gas Plasma Sterilization Indicator StripJOJ · Traditional | Kimberly-Clark Corp. | 07/10/1998SE |
| K971971 | Browne TST Single Use Bowie-Dick Type Test PackJOJ · Traditional | Board of Directors, Albert Browne , Ltd. | 07/10/1998SE |
| K965212 | Steritec Disposable Integrator Load Challenge-SteamJOJ · Traditional | Steritec Products Mfg Co, Inc. | 04/23/1998SE |
| K972300 | Cross-Checks PJOJ · Traditional | Steritec Products Mfg Co, Inc. | 03/25/1998SE |
| K971369 | Browne Mvi Steam IndicatorJOJ · Traditional | Albert Browne , Ltd. | 01/29/1998SE |
| K971888 | GlutatectJOJ · Traditional | Alden Scientific, Inc. | 01/09/1998SE |
| K972035 | Sporox Test StripsJOJ · Traditional | Serim Research Corp. | 08/29/1997SE |
| K970918 | Browne Steam IndicatorJOJ · Traditional | Board of Directors, Albert Browne , Ltd. | 06/24/1997SE |
| K960441 | Steritec Integraph Model CI-101JOJ · Traditional | Steritec Products Mfg Co, Inc. | 05/08/1997SE |
| K953122 | Steritec Dry Heat Indicator LabelJOJ · Traditional | Steritec Products Mfg Co, Inc. | 04/02/1997SE |
| K961156 | Once-A-Day Bowie and Dick Test Pack.JOJ · Traditional | Propper Mfg. Co., Inc. | 04/01/1997SE |
| K952244 | Cross-Checks Eo Gas Sterilization MonitorJOJ · Traditional | Steritec Products Mfg Co, Inc. | 08/05/1996SE |
| K960089 | Prochek G Glutaraldehyde Concentration Level IndicatorJOJ · Traditional | Cottrell, Ltd. | 04/04/1996SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0836-2024 Class II | Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical…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-1610-2023 Class II | 3M Attest Steam Chemical Integrators, REF 1243B3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023… | 3M Company - Health Care Business | 04/06/2023Open, Classified |
| Z-1609-2023 Class II | 3M Attest Steam Chemical Integrators, REF 1243A3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023… | 3M Company - Health Care Business | 04/06/2023Open, Classified |
| Z-1736-2022 Class III | Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam…Product contains incorrect chemical indicators in packaging. | Steris Corporation Hopkins Facility | 08/10/2022Terminated |
| Z-1794-2022 Class III | a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1792-2022 Class III | a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0555-2022 Class II | YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF…The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. | Young Dental Mfg Co I LLC | 12/29/2021Open, Classified |
| Z-2699-2020 Class II | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG -…The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not… | Resource Optimization & Innovation LLC | 06/17/2020Terminated |
| Z-1166-2014 Class II | VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH…STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge… | Steris Corporation | 12/19/2013Terminated |
| Z-1829-2013 Class II | Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec 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-1828-2013 Class II | Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code…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-3046-2011 | Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By:…During an inspection the firm was notified that language contained in labeling and promotional literature… | Steris Corporation | 03/16/2011Terminated |
| Z-3045-2011 | Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031…During an inspection the firm was notified that language contained in labeling and promotional literature… | Steris Corporation | 03/16/2011Terminated |
| Z-1532-2010 | Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.This action notifies affected SteriTec customers as well as private label distributors of the necessity to… | Steritec Products Mfc. Co., Inc. | 07/15/2009Terminated |
| Z-1531-2010 | Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick).…This action notifies affected SteriTec customers as well as private label distributors of the necessity to… | Steritec Products Mfc. Co., Inc. | 07/15/2009Terminated |
| Z-1568-2008 | 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical…A production specification discrepancy may cause the indicators to show an inaccurate result, which could… | 3M Company / Medical Division | 03/19/2008Terminated |
| Z-2330-2008 | Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No.…The firm discovered a production specification discrepancy that may cause the indicators to show an… | Propper Mfg Co Inc | 02/07/2008Terminated |
| Z-0027-2007 | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S…3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of… | 3M Company / Medical Division | 08/09/2006Terminated |