FDA Product Code
FDA Product Code JOJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2800
510(k) Clearances — 265 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261992 | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | 2026-09-25 | Traditional | PDF ↗ |
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026-02-20 | Special | PDF ↗ |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 | Traditional | PDF ↗ |
| K251035 | DISINTEK PA Test Strips | Serim Research | 2025-06-03 | Traditional | PDF ↗ |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025-05-02 | Special | PDF ↗ |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | 2025-04-25 | Special | PDF ↗ |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 | Special | PDF ↗ |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | 2025-01-17 | Traditional | PDF ↗ |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 | Traditional | PDF ↗ |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024-12-04 | Special | PDF ↗ |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 | Special | PDF ↗ |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | 2024-09-30 | Traditional | PDF ↗ |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024-08-20 | Special | PDF ↗ |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | Advanced Sterilization Products, Inc. | 2024-07-05 | Traditional | PDF ↗ |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024-06-26 | Traditional | PDF ↗ |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024-06-12 | Abbreviated | PDF ↗ |
| K241344 | MetriCide OPA Plus Solution Test Strip | Steris | 2024-06-11 | Special | PDF ↗ |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024-04-17 | Traditional | PDF ↗ |
| K240760 | CELERITY HP Indicator Tape | Steris | 2024-04-10 | Special | PDF ↗ |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Steris | 2023-12-08 | Special | PDF ↗ |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris | 2023-10-27 | Special | PDF ↗ |
| K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | Steris | 2023-08-07 | Traditional | PDF ↗ |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation | 2023-07-17 | Traditional | PDF ↗ |
| K222137 | OK Plus Indicator | Propper Manufacturing Co., Inc. | 2022-12-05 | Abbreviated | PDF ↗ |
| K220778 | Chemical Indicator for Steam | True Indicating, LLC | 2022-12-02 | Traditional | PDF ↗ |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2022-11-01 | Traditional | PDF ↗ |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2022-09-23 | Traditional | PDF ↗ |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022-06-24 | Special | PDF ↗ |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | 3M Company | 2022-05-23 | Traditional | PDF ↗ |
| K213412 | VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM | Steris Corparation | 2022-01-21 | Traditional | PDF ↗ |
| K212592 | Gas-Chex Indicator | Propper Manufacturing Co., Inc. | 2022-01-20 | Abbreviated | PDF ↗ |
| K212081 | 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2021-09-05 | Special | PDF ↗ |
| K200096 | Crosstex VH2O2 Chemical Indicators | Crosstex International, Inc. (A Cantel Medical Company) | 2021-07-15 | Special | PDF ↗ |
| K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021-06-21 | Abbreviated | PDF ↗ |
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021-05-19 | Abbreviated | PDF ↗ |
| K203458 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2020-12-11 | Special | PDF ↗ |
| K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2020-12-10 | Special | PDF ↗ |
| K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corporation | 2020-12-02 | Traditional | PDF ↗ |
| K200334 | AN1036 Dosimeter | Andersen Sterilizers, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K200272 | Terragene Chemdye | Terragene S.A. | 2020-06-30 | Traditional | PDF ↗ |
| K200252 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg Co, Inc. | 2020-05-21 | Traditional | PDF ↗ |
| K192445 | QwikCheck Chemical Indicators | Serim Research Corporation | 2020-04-02 | Traditional | PDF ↗ |
| K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019-12-23 | Special | PDF ↗ |
| K191236 | 3M Attest Steam Chemical Integrators | 3M Company | 2019-11-22 | Traditional | PDF ↗ |
| K192937 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019-11-16 | Special | PDF ↗ |
| K192673 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2019-10-28 | Special | PDF ↗ |
| K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | 2019-10-21 | Traditional | PDF ↗ |
| K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label | STERIS Corporation | 2019-09-05 | Special | PDF ↗ |
| K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape | Intertape Polymer, Inc. | 2019-08-02 | Special | PDF ↗ |
| K181788 | Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corp. | 2019-03-01 | Traditional | PDF ↗ |
| K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019-02-26 | Traditional | PDF ↗ |
| K183209 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2019-02-15 | Traditional | PDF ↗ |
| K183293 | VERIFY VH202 Indicator Tape | STERIS Corporation | 2019-01-04 | Traditional | PDF ↗ |
| K183295 | Celerity HP Chemical Indicator (CI) | Steris Corporations | 2019-01-04 | Abbreviated | PDF ↗ |
| K182724 | CelerityTM 10 STEAM Chemical Indicator | STERIS Corporation | 2018-12-10 | Traditional | PDF ↗ |
| K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018-03-02 | Traditional | PDF ↗ |
| K171823 | U&U Indicator tape and strip | U&U Medical Technology Co, Ltd. | 2018-02-22 | Traditional | PDF ↗ |
| K172753 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2018-02-09 | Traditional | PDF ↗ |
| K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label | STERIS Corporation | 2018-02-09 | Abbreviated | PDF ↗ |
| K172472 | Micro-MEC 1.8% Glutaraldehyde Monitor Strip | STERIS Corporation | 2017-11-17 | Traditional | PDF ↗ |
| K170439 | AN87 Dosimeter | Andersen Sterilizers, Inc. | 2017-11-01 | Traditional | PDF ↗ |
| K170426 | AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. | 2017-10-30 | Traditional | PDF ↗ |
| K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017-08-14 | Traditional | PDF ↗ |
| K170563 | 3M Comply Hydrogen Peroxide Indicator Tape | 3M Company | 2017-07-27 | Traditional | PDF ↗ |
| K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack | STERIS Corporation | 2017-03-21 | Traditional | PDF ↗ |
| K162631 | VERIFY STEAM Integrating Indicator - Short | STERIS Corporation | 2017-01-27 | Traditional | PDF ↗ |
| K161024 | Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape | Canadian Technical Tape, Ltd. | 2016-06-28 | Special | PDF ↗ |
| K160485 | VERIFY VH2O2 Indicator Tape | STERIS Corporation | 2016-06-01 | Traditional | PDF ↗ |
| K152630 | VERIFY STEAM Integrating Indicator | STERIS Corporation | 2016-05-12 | Traditional | PDF ↗ |
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | Medivators, Inc. | 2016-03-11 | Traditional | PDF ↗ |
| K150645 | AN1087 Dosimeter | Andersen Sterilizers, Inc. | 2015-11-19 | Traditional | PDF ↗ |
| K150644 | AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. | 2015-11-18 | Traditional | PDF ↗ |
| K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | 2015-10-01 | Traditional | PDF ↗ |
| K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015-09-29 | Traditional | PDF ↗ |
| K150477 | 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization | 3M Company | 2015-07-02 | Traditional | PDF ↗ |
| K143520 | SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) | Crosstex | 2015-06-09 | Traditional | PDF ↗ |
| K143629 | U&U Bowie-Dick Test Pack | U&U Medical Technology Co, Ltd. | 2015-05-19 | Traditional | PDF ↗ |
| K143333 | Revital-Ox RESERT Solution Test Strip | STERIS Corporation | 2015-04-14 | Traditional | PDF ↗ |
| K141698 | STERIZONE CHEMICAL INDICATOR | Tso3, Inc. | 2014-12-17 | Traditional | PDF ↗ |
| K140566 | SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE | Crosstex International | 2014-11-24 | Traditional | PDF ↗ |
| K140940 | PROCESS INDICATOR TAPE FOR STEAM STERILIZATION | Canadian Technical Tape, Ltd. | 2014-10-27 | Traditional | PDF ↗ |
| K140515 | VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL | STERIS Corporation | 2014-07-17 | Abbreviated | PDF ↗ |
| K132291 | NAMSA CHEMICAL PROCESS | North American Science Assoc., Inc. | 2014-05-20 | Traditional | PDF ↗ |
| K133204 | AIRVIEW MINI OWIE DICK TEST PACK | Crosstex International | 2014-05-05 | Traditional | PDF ↗ |
| K132372 | STERITEC GREEN CARD PACK BOWIE-DICK TEST | Steritec Products Mfg Co, Inc. | 2013-11-26 | Traditional | PDF ↗ |
| K130135 | DANA REUSABLE BI TEST PACK | Dana Products, Inc. | 2013-11-25 | Traditional | PDF ↗ |
| K130160 | VERIFY PROCESS INDICATOR FOR RELIANCE EPS | STERIS Corporation | 2013-08-16 | Traditional | PDF ↗ |
| K130211 | AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS | Spsmedical Supply Corp. | 2013-07-05 | Special | PDF ↗ |
| K122945 | STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 | Steritec Products Mfg Co, Inc. | 2013-04-30 | Abbreviated | PDF ↗ |
| K120592 | DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS | Dana Products, Inc. | 2013-02-27 | Traditional | PDF ↗ |
| K122555 | STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE | Steritec Products Mfg Co, Inc. | 2012-12-12 | Abbreviated | PDF ↗ |
| K120652 | RAPICIDE OPA-28 TEST STRIP | Serim Research Corp. | 2012-10-12 | Traditional | PDF ↗ |
| K111518 | STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 | Advanced Sterilization Products | 2012-10-03 | Traditional | PDF ↗ |
| K111519 | STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 | Advanced Sterilization Products | 2012-10-03 | Traditional | PDF ↗ |
| K120435 | BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR | STERIS Corporation | 2012-06-04 | Traditional | PDF ↗ |
| K111453 | STEAM DOT BLU PROCESS INDICATOR | Propper Mfg. Co., Inc. | 2012-04-05 | Abbreviated | PDF ↗ |
| K112256 | STERIS STEAM PI | STERIS Corporation | 2012-01-11 | Abbreviated | PDF ↗ |
| K103331 | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES | STERIS Corporation | 2011-09-01 | Traditional | PDF ↗ |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | Propper Mfg. Co., Inc. | 2011-05-25 | Abbreviated | PDF ↗ |
| K110369 | INDISTRIP GREEN | Indilab, Inc. | 2011-05-06 | Traditional | PDF ↗ |
Product code JOJ · Class II · General Hospital. Data: openFDA.