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 Advanced Sterilization Products.

265
Total
264
Cleared
152d
Avg days
1976
Since
265 devices
97–120 of 265
Cleared Apr 02, 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742
Advanced Sterilization Products
General Hospital · 10d
Cleared Oct 08, 2002
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441
Advanced Sterilization Products
General Hospital · 75d
Cleared Apr 22, 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589
3M Company
General Hospital · 59d
Cleared Jul 10, 1998
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415
Kimberly-Clark Corp.
General Hospital · 228d
Cleared Dec 29, 1994
STERRAD CHEMICAL INDICATOR TAPE
K945190
Advanced Sterilization Products
General Hospital · 66d
Cleared Mar 04, 1994
3M AUTOCLAVE TAPES
K932129
3M Company
General Hospital · 305d
Cleared Oct 04, 1993
STERRAD CHEMICAL INDICATOR
K921910
Johnson & Johnson Medical, Inc.
General Hospital · 529d
Cleared Sep 29, 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485
American Sterilizer Co.
General Hospital · 499d
Cleared Feb 15, 1990
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045
Edward Weck, Inc.
General Hospital · 58d
Cleared Nov 29, 1989
TOWER SELF SEAL STERILIZATION POUCH
K895422
Baxter Healthcare Corp
General Hospital · 89d
Cleared Mar 21, 1985
DART DAILY AIR REMOVAL TEST
K844512
American Sterilizer Co.
General Hospital · 121d
Cleared May 09, 1984
STERILIZATION PROCESS INDICATOR
K841168
Parke-Davis Co.
General Hospital · 51d
Cleared Nov 08, 1982
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074
American Sterilizer Co.
General Hospital · 20d
Cleared Jul 28, 1981
CHEMICAL AUTOCLAVE INDICATOR TAPE
K811936
American Hospital Supply Corp.
General Hospital · 22d
Cleared Jun 24, 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614
Sybron Corp.
General Hospital · 107d
Cleared Dec 11, 1980
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634
Organon, Inc.
General Hospital · 50d
Cleared Aug 13, 1980
CHEMDI
K801428
American Sterilizer Co.
General Hospital · 57d
Cleared Jun 17, 1980
3M STEAM STERILIZATION INDICATOR
K801057
3M Company
General Hospital · 42d
Cleared Jan 11, 1980
STERILIZATION PROCESS/ MAYO PAD
K792624
Procter & Gamble Mfg. Co.
General Hospital · 23d