JOJ · Class II · 21 CFR 880.2800

FDA Product Code JOJ: Indicator, Physical/chemical Sterilization Process

FDA product code JOJ covers physical and chemical sterilization process indicators.

These indicators use temperature-sensitive inks, chemical reactions, or physical changes to confirm that instruments have been exposed to sterilization conditions. They provide a visual, immediate confirmation that packages have passed through the sterilization cycle, distinguishing processed from unprocessed items.

JOJ devices are Class II medical devices, regulated under 21 CFR 880.2800 and reviewed by the FDA General Hospital panel.

Leading manufacturers include STERIS Corporation, 3M Company and Spsmedical Supply Corp..

265
Total
264
Cleared
152d
Avg days
1976
Since
265 devices
49–72 of 265
Cleared Aug 02, 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
K191741
Intertape Polymer, Inc.
General Hospital · 32d
Cleared Mar 01, 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788
Kem Medical Products Corp.
General Hospital · 239d
Cleared Feb 26, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K183211
3M Company
General Hospital · 99d
Cleared Feb 15, 2019
3M Comply Hydrogen Peroxide Indicator Tape
K183209
3M Company
General Hospital · 88d
Cleared Jan 04, 2019
VERIFY VH202 Indicator Tape
K183293
STERIS Corporation
General Hospital · 38d
Cleared Jan 04, 2019
Celerity HP Chemical Indicator (CI)
K183295
Steris Corporations
General Hospital · 38d
Cleared Dec 10, 2018
CelerityTM 10 STEAM Chemical Indicator
K182724
STERIS Corporation
General Hospital · 73d
Cleared Mar 02, 2018
VERIFY Chemical Indicator for S40 Sterilant
K173428
STERIS Corporation
General Hospital · 120d
Cleared Feb 22, 2018
U&U Indicator tape and strip
K171823
U&U Medical Technology Co, Ltd.
General Hospital · 248d
Cleared Feb 09, 2018
VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
K172746
STERIS Corporation
General Hospital · 150d
Cleared Feb 09, 2018
VERIFY VH2O2 Indicator Tape
K172753
STERIS Corporation
General Hospital · 150d
Cleared Nov 17, 2017
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472
STERIS Corporation
General Hospital · 94d
Cleared Nov 01, 2017
AN87 Dosimeter
K170439
Andersen Sterilizers, Inc.
General Hospital · 261d
Cleared Oct 30, 2017
AN85/AN86 EO Indicators
K170426
Andersen Sterilizers, Inc.
General Hospital · 259d
Cleared Aug 14, 2017
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K170321
3M Company
General Hospital · 194d
Cleared Jul 27, 2017
3M Comply Hydrogen Peroxide Indicator Tape
K170563
3M Company
General Hospital · 150d
Cleared Mar 21, 2017
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack
K162758
STERIS Corporation
General Hospital · 172d
Cleared Jan 27, 2017
VERIFY STEAM Integrating Indicator - Short
K162631
STERIS Corporation
General Hospital · 128d
Cleared Jun 28, 2016
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
K161024
Canadian Technical Tape, Ltd.
General Hospital · 77d
Cleared Jun 01, 2016
VERIFY VH2O2 Indicator Tape
K160485
STERIS Corporation
General Hospital · 100d
Cleared May 12, 2016
VERIFY STEAM Integrating Indicator
K152630
STERIS Corporation
General Hospital · 240d
Cleared Mar 11, 2016
Rapicide PA High-Level Disinfectant Test Strips
K152394
Medivators, Inc.
General Hospital · 200d
Cleared Nov 19, 2015
AN1087 Dosimeter
K150645
Andersen Sterilizers, Inc.
General Hospital · 252d
Cleared Nov 18, 2015
AN85/AN86 EO Indicators
K150644
Andersen Sterilizers, Inc.
General Hospital · 251d