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, 3M Company and STERIS Corporation.

17
Total
16
Cleared
73d
Avg days
2021
Since

List of Indicator, Physical/chemical Sterilization Process devices cleared through 510(k)

17 devices
1–17 of 17
Cleared May 02, 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048
STERIS Corporation
General Hospital · 29d
Cleared Apr 25, 2025
VERIFY STEAM Integrating Indicator
K243876
STERIS Corporation
General Hospital · 128d
Cleared Dec 04, 2024
Chemical Indicator for enspire CLCSPS (LCC015)
K243475
STERIS Corporation
General Hospital · 26d
Cleared Aug 20, 2024
CELERITY HP Indicator Tape (PCC077)
K242189
Steris
General Hospital · 26d
Cleared Jun 11, 2024
MetriCide™ OPA Plus Solution Test Strip
K241344
Steris
General Hospital · 29d
Not Cleared May 21, 2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
DEN230068
3M Company
General Hospital · 235d
Cleared Apr 17, 2024
Celerity Chemical Indicator for enspire 3000 CLCSPS
K240032
STERIS Corporation
General Hospital · 104d
Cleared Apr 10, 2024
CELERITY HP Indicator Tape
K240760
Steris
General Hospital · 21d
Cleared Dec 08, 2023
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
K233654
Steris
General Hospital · 24d
Cleared Oct 27, 2023
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187
Steris
General Hospital · 29d
Cleared Aug 07, 2023
Celerity™ HP Chemical Indicator
K231488
Steris
General Hospital · 76d
Cleared Jul 17, 2023
Revital-Ox PAA High Level Disinfectant Chemical Indicator
K230558
STERIS Corporation
General Hospital · 139d
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 Sep 05, 2021
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
K212081
3M Company
General Hospital · 65d

How to use this database

This page lists all FDA 510(k) submissions for Indicator, Physical/chemical Sterilization Process devices (product code JOJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →