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
193–216 of 265
Cleared Aug 07, 1989
C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR
K890757
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
DRY HEAT STERILIZATION INDICATOR TAPE
K890758
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR
K890759
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR, E.O. GAS
K890760
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR
K890761
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
LABEL, STERILIZATION INDICATOR
K890763
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
LABEL, STERILIZATION INDICATOR
K890764
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR
K890765
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Jul 16, 1985
BIO-CHALLENGE TEST PAK
K851804
Propper Mfg. Co., Inc.
General Hospital · 77d
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 Mar 19, 1984
OK FLASH STERILIZATION INDICATOR
K834353
Propper Mfg. Co., Inc.
General Hospital · 97d
Cleared Nov 07, 1983
CASTLE TEC-TEST S.M.A.R.T. PACK
K833074
Castle Co.
General Hospital · 59d
Cleared Nov 08, 1982
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074
American Sterilizer Co.
General Hospital · 20d
Cleared Jun 22, 1982
GAS CHEX PLASTIC BAG
K821648
Propper Mfg. Co., Inc.
General Hospital · 18d
Cleared Nov 10, 1981
PROTECT-O-SEAL
K813014
Tri-Med, Inc.
General Hospital · 14d
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 May 30, 1980
PROOF (BIOLOGICAL/CHEMICAL INDICATOR)
K801109
Amsco Co.
General Hospital · 18d
Cleared Jan 11, 1980
STERILIZATION PROCESS/ MAYO PAD
K792624
Procter & Gamble Mfg. Co.
General Hospital · 23d
Cleared Dec 08, 1977
BIOLOGICAL/CHEMICAL INDICATOR
K772135
Amsco Co.
General Hospital · 24d