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 3M Company, STERIS Corporation and Steris.

265
Total
264
Cleared
152d
Avg days
1976
Since
265 devices
25–48 of 265
Cleared Dec 02, 2022
Chemical Indicator for Steam
K220778
True Indicating, LLC
General Hospital · 260d
Cleared Nov 01, 2022
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
K222508
3M Company
General Hospital · 75d
Cleared Sep 23, 2022
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
K222152
3M Company
General Hospital · 65d
Cleared Jun 24, 2022
3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
K220942
3M Company
General Hospital · 85d
Cleared May 23, 2022
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
K220564
3M Company
General Hospital · 84d
Cleared Jan 21, 2022
VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
K213412
Steris Corparation
General Hospital · 94d
Cleared Jan 20, 2022
Gas-Chex Indicator
K212592
Propper Manufacturing Co., Inc.
General Hospital · 157d
Cleared Sep 05, 2021
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
K212081
3M Company
General Hospital · 65d
Cleared Jul 15, 2021
Crosstex VH2O2 Chemical Indicators
K200096
Crosstex International, Inc. (A Cantel Medical Company)
General Hospital · 546d
Cleared Jun 21, 2021
Steri-Dot Process Indicator
K210866
Propper Manufacturing Co., Inc.
General Hospital · 90d
Cleared May 19, 2021
Steam-Dot Process Indicator
K210553
Propper Manufacturing Co., Inc.
General Hospital · 83d
Cleared Dec 11, 2020
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K203458
3M Company
General Hospital · 17d
Cleared Dec 10, 2020
3M Comply Hydrogen Peroxide Indicator Tape 1228
K203285
3M Company
General Hospital · 31d
Cleared Dec 02, 2020
WAVICIDE-OPA MEC Indicator
K202565
Serim Research Corporation
General Hospital · 89d
Cleared Nov 12, 2020
AN1036 Dosimeter
K200334
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Jun 30, 2020
Terragene Chemdye
K200272
Terragene S.A.
General Hospital · 147d
Cleared May 21, 2020
Getinge Assured MI Steam Migrating Integrator
K200252
Steritec Products Mfg Co, Inc.
General Hospital · 108d
Cleared Apr 02, 2020
QwikCheck Chemical Indicators
K192445
Serim Research Corporation
General Hospital · 209d
Cleared Dec 23, 2019
3M Attest Steam Chemical Integrator
K193254
3M Company
General Hospital · 27d
Cleared Nov 22, 2019
3M™ Attest™ Steam Chemical Integrators
K191236
3M Company
General Hospital · 198d
Cleared Nov 16, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K192937
3M Company
General Hospital · 29d
Cleared Oct 28, 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673
3M Company
General Hospital · 32d
Cleared Oct 21, 2019
Sterilucent VH2O2 Chemical Indicators
K191999
Sterilucent, Inc.
General Hospital · 87d
Cleared Sep 05, 2019
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
K192020
STERIS Corporation
General Hospital · 38d