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
169–192 of 265
Cleared Jan 09, 1998
GLUTATECT
K971888
Alden Scientific, Inc.
General Hospital · 233d
Cleared Aug 29, 1997
SPOROX TEST STRIPS
K972035
Serim Research Corp.
General Hospital · 88d
Cleared Jun 24, 1997
BROWNE STEAM INDICATOR
K970918
Board of Directors, Albert Browne , Ltd.
General Hospital · 104d
Cleared May 08, 1997
STERITEC INTEGRAPH MODEL CI-101
K960441
Steritec Products Mfg Co, Inc.
General Hospital · 462d
Cleared Apr 02, 1997
STERITEC DRY HEAT INDICATOR LABEL
K953122
Steritec Products Mfg Co, Inc.
General Hospital · 637d
Cleared Apr 01, 1997
ONCE-A-DAY BOWIE AND DICK TEST PACK.
K961156
Propper Mfg. Co., Inc.
General Hospital · 375d
Cleared Aug 05, 1996
CROSS-CHECKS EO GAS STERILIZATION MONITOR
K952244
Steritec Products Mfg Co, Inc.
General Hospital · 451d
Cleared Apr 04, 1996
PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
K960089
Cottrell, Ltd.
General Hospital · 84d
Cleared Mar 12, 1996
STERITEC CROSS-CHECKS
K955426
Steritec Products Mfg Co, Inc.
General Hospital · 105d
Cleared Feb 22, 1996
ATI ETHYLENE OXIDE STERILIZATION INDICATOR
K952995
Pymah Corp.
General Hospital · 239d
Cleared Jul 06, 1995
ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
K952408
Pymah Corp.
General Hospital · 45d
Cleared May 10, 1995
ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION
K951063
Pymah Corp.
General Hospital · 63d
Cleared Apr 18, 1995
STERIGAGE EO 100%
K934874
Pymah Corp.
General Hospital · 553d
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 Feb 07, 1994
ENDPOINT 500 PERACETIC ACID TEST INDICATORS
K931935
Minntech Corp.
General Hospital · 294d
Cleared Nov 17, 1993
GLUTARALDEHYDE MONITORS
K924681
Pymah Corp.
General Hospital · 427d
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 May 01, 1991
SERIM PERACETIC ACID REAGENT STRIPS
K910320
Serim Research Corp.
General Hospital · 97d
Cleared Aug 22, 1990
STEAMLINE
K895910
Propper Mfg. Co., Inc.
General Hospital · 316d
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 Aug 07, 1989
SEALING TAPE, STERILIZATION INDICATOR
K890755
Spsmedical Supply Corp.
General Hospital · 174d