Atlas FDA

JOJ

264 FDA 510(k) clearances · Product code

119 daysmedian time to decision
301 days90th percentile
264clearances measured

FDA profile

Official device name
Indicator, Physical/Chemical Sterilization Process
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2800
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 12 · 2021: 29 · 2022: 23 · 2023: 39 · 2024: 25 · 2026: 53
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LF Process Indicator Tape for Steam Sterilization (K260181)Intertape Polymer Group2026-02-20
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (K251991)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2025-12-23
DISINTEK™ PA Test Strips (K251035)Serim Research2025-06-03
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048)STERIS Corporation2025-05-02
VERIFY STEAM Integrating Indicator (K243876)STERIS Corporation2025-04-25
Green Card Bowie-Dick Test (BD115) (K250172)Steritec Products, Inc. (A Getinge Company)2025-02-20
Type 5 Integrating Indicator for Steam (CSPN-15) (K242860)True Indicating, LLC2025-01-17
Autoclave Indicator Tape; EO Indicator Tape (K241036)Jiangmen New Era External Use Drug Co., Ltd.2024-12-17
Chemical Indicator for enspire CLCSPS (LCC015) (K243475)STERIS Corporation2024-12-04
Getinge Assured MI Steam Migrating Integrator (K242795)Steritec Products Mfg. (A Getinge Group Company)2024-10-15
Kem Medical Lead-free Chemical Indicators for Steam Sterilization (K241836)Kem Medical Products Corporation2024-09-30
CELERITY HP Indicator Tape (PCC077) (K242189)Steris2024-08-20
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) (K234084)Advanced Sterilization Products, Inc.2024-07-05
Ultraphon Chemical Indicator (TRO-T and TRO-B) (K233413)True Indicating, LLC2024-06-26
EO Chex Indicator Tape (K240910)Propper Manufacturing Co., Inc.2024-06-12
MetriCide™ OPA Plus Solution Test Strip (K241344)Steris2024-06-11
Celerity Chemical Indicator for enspire 3000 CLCSPS (K240032)STERIS Corporation2024-04-17
CELERITY HP Indicator Tape (K240760)Steris2024-04-10
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (K233654)Steris2023-12-08
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) (K233187)Steris2023-10-27
Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape (K231488)Steris2023-08-07
Revital-Ox PAA High Level Disinfectant Chemical Indicator (K230558)STERIS Corporation2023-07-17
OK Plus Indicator (K222137)Propper Manufacturing Co., Inc.2022-12-05
Chemical Indicator for Steam (K220778)True Indicating, LLC2022-12-02
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K222508)3M Company2022-11-01
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 (K222152)3M Company2022-09-23
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) (K220942)3M Company2022-06-24
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 (K220564)3M Company2022-05-23
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM (K213412)Steris Corparation2022-01-21
Gas-Chex Indicator (K212592)Propper Manufacturing Co., Inc.2022-01-20
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 (K212081)3M Company2021-09-05
Crosstex VH2O2 Chemical Indicators (K200096)Crosstex International, Inc. (A Cantel Medical Company)2021-07-15
Steri-Dot Process Indicator (K210866)Propper Manufacturing Co., Inc.2021-06-21
Steam-Dot Process Indicator (K210553)Propper Manufacturing Co., Inc.2021-05-19
3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K203458)3M Company2020-12-11
3M Comply Hydrogen Peroxide Indicator Tape 1228 (K203285)3M Company2020-12-10
WAVICIDE-OPA MEC Indicator (K202565)Serim Research Corporation2020-12-02
AN1036 Dosimeter (K200334)Andersen Sterilizers, Inc.2020-11-12
Terragene Chemdye (K200272)Terragene S.A.2020-06-30
Getinge Assured MI Steam Migrating Integrator (K200252)Steritec Products Mfg Co, Inc.2020-05-21
QwikCheck Chemical Indicators (K192445)Serim Research Corporation2020-04-02
3M Attest Steam Chemical Integrator (K193254)3M Company2019-12-23
3M™ Attest™ Steam Chemical Integrators (K191236)3M Company2019-11-22
3M Comply Hydrogen Peroxide Chemical Indicator (K192937)3M Company2019-11-16
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (K192673)3M Company2019-10-28
Sterilucent VH2O2 Chemical Indicators (K191999)Sterilucent, Inc.2019-10-21
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label (K192020)STERIS Corporation2019-09-05
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape (K191741)Intertape Polymer, Inc.2019-08-02
Lead-free Chemical Indicators for Steam Sterilization (K181788)Kem Medical Products Corp.2019-03-01
3M Comply Hydrogen Peroxide Chemical Indicator (K183211)3M Company2019-02-26
3M Comply Hydrogen Peroxide Indicator Tape (K183209)3M Company2019-02-15
VERIFY VH202 Indicator Tape (K183293)STERIS Corporation2019-01-04
Celerity HP Chemical Indicator (CI) (K183295)Steris Corporations2019-01-04
CelerityTM 10 STEAM Chemical Indicator (K182724)STERIS Corporation2018-12-10
VERIFY Chemical Indicator for S40 Sterilant (K173428)STERIS Corporation2018-03-02
U&U Indicator tape and strip (K171823)U&U Medical Technology Co, Ltd.2018-02-22
VERIFY VH2O2 Indicator Tape (K172753)STERIS Corporation2018-02-09
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label (K172746)STERIS Corporation2018-02-09
Micro-MEC 1.8% Glutaraldehyde Monitor Strip (K172472)STERIS Corporation2017-11-17
AN87 Dosimeter (K170439)Andersen Sterilizers, Inc.2017-11-01
AN85/AN86 EO Indicators (K170426)Andersen Sterilizers, Inc.2017-10-30
3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K170321)3M Company2017-08-14
3M Comply Hydrogen Peroxide Indicator Tape (K170563)3M Company2017-07-27
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (K162758)STERIS Corporation2017-03-21
VERIFY STEAM Integrating Indicator - Short (K162631)STERIS Corporation2017-01-27
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape (K161024)Canadian Technical Tape, Ltd.2016-06-28
VERIFY VH2O2 Indicator Tape (K160485)STERIS Corporation2016-06-01
VERIFY STEAM Integrating Indicator (K152630)STERIS Corporation2016-05-12
Rapicide PA High-Level Disinfectant Test Strips (K152394)Medivators, Inc.2016-03-11
AN1087 Dosimeter (K150645)Andersen Sterilizers, Inc.2015-11-19
AN85/AN86 EO Indicators (K150644)Andersen Sterilizers, Inc.2015-11-18
3M Comply Hydrogen Peroxide Indicator Tape 1228 (K150694)3M Company2015-10-01
3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K150622)3M Company2015-09-29
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization (K150477)3M Company2015-07-02
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) (K143520)Crosstex2015-06-09
U&U Bowie-Dick Test Pack (K143629)U&U Medical Technology Co, Ltd.2015-05-19
Revital-Ox RESERT Solution Test Strip (K143333)STERIS Corporation2015-04-14
STERIZONE CHEMICAL INDICATOR (K141698)Tso3, Inc.2014-12-17
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE (K140566)Crosstex International2014-11-24
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION (K140940)Canadian Technical Tape, Ltd.2014-10-27
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL (K140515)STERIS Corporation2014-07-17
NAMSA CHEMICAL PROCESS (K132291)North American Science Assoc., Inc.2014-05-20
AIRVIEW MINI OWIE DICK TEST PACK (K133204)Crosstex International2014-05-05
STERITEC GREEN CARD PACK BOWIE-DICK TEST (K132372)Steritec Products Mfg Co, Inc.2013-11-26
DANA REUSABLE BI TEST PACK (K130135)Dana Products, Inc.2013-11-25
VERIFY PROCESS INDICATOR FOR RELIANCE EPS (K130160)STERIS Corporation2013-08-16
AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS (K130211)Spsmedical Supply Corp.2013-07-05
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 (K122945)Steritec Products Mfg Co, Inc.2013-04-30
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS (K120592)Dana Products, Inc.2013-02-27
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE (K122555)Steritec Products Mfg Co, Inc.2012-12-12
RAPICIDE OPA-28 TEST STRIP (K120652)Serim Research Corp.2012-10-12
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 (K111519)Advanced Sterilization Products2012-10-03
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 (K111518)Advanced Sterilization Products2012-10-03
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR (K120435)STERIS Corporation2012-06-04
STEAM DOT BLU PROCESS INDICATOR (K111453)Propper Mfg. Co., Inc.2012-04-05
STERIS STEAM PI (K112256)STERIS Corporation2012-01-11
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES (K103331)STERIS Corporation2011-09-01
CLASSIX CHEMICAL STERILIZATION INDICATOR (K102894)Propper Mfg. Co., Inc.2011-05-25
INDISTRIP GREEN (K110369)Indilab, Inc.2011-05-06
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS (K110253)Dana Products, Inc.2011-04-29
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