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
97–120 of 265
Cleared Jan 11, 2012
STERIS STEAM PI
K112256
STERIS Corporation
General Hospital · 159d
Cleared Sep 01, 2011
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
K103331
STERIS Corporation
General Hospital · 293d
Cleared May 25, 2011
CLASSIX CHEMICAL STERILIZATION INDICATOR
K102894
Propper Mfg. Co., Inc.
General Hospital · 237d
Cleared May 06, 2011
INDISTRIP GREEN
K110369
Indilab, Inc.
General Hospital · 87d
Cleared Apr 29, 2011
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
K110253
Dana Products, Inc.
General Hospital · 91d
Cleared Apr 15, 2011
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
K110152
Spsmedical Supply Corp.
General Hospital · 86d
Cleared Apr 01, 2011
STERRAD CHEMICAL INDICATOR STRIP
K103218
Advanced Sterilization Products
General Hospital · 151d
Cleared Apr 01, 2011
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219
Advanced Sterilization Products
General Hospital · 151d
Cleared Mar 10, 2011
VERIFY 270FP CHALLENGE PACK
K103053
STERIS Corporation
General Hospital · 146d
Cleared Feb 11, 2011
SMART READ BIOLOGICAL TEST PACK
K103000
Steritec Products Mfg Co, Inc.
General Hospital · 126d
Cleared Feb 09, 2011
VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)
K102296
STERIS Corporation
General Hospital · 180d
Cleared Jan 27, 2011
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
K102363
Spsmedical Supply Corp.
General Hospital · 160d
Cleared Nov 22, 2010
SYSTEM 1E CHEMICAL INDICATOR
K102217
STERIS Corporation
General Hospital · 108d
Cleared Oct 01, 2010
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
K101528
3M Company
General Hospital · 121d
Cleared Sep 08, 2010
STERIGAGE MODEL 1243RA, 1243RB, 1243RE
K101249
3M Company
General Hospital · 127d
Cleared Jan 07, 2010
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
K092346
Serim Research Corp.
General Hospital · 156d
Cleared Dec 04, 2009
3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK
K093199
3M Company
General Hospital · 56d
Cleared Oct 27, 2009
VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR
K091174
STERIS Corporation
General Hospital · 188d
Cleared Oct 09, 2009
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
K090650
Spsmedical Supply Corp.
General Hospital · 212d
Cleared Aug 07, 2009
VERIFY 275F GRAVITY INDICATORS
K083643
STERIS Corporation
General Hospital · 241d
Cleared Jul 08, 2009
ONCE-A-DAY VERTOS TEST PACK
K082620
Propper Mfg. Co., Inc.
General Hospital · 302d
Cleared Mar 16, 2009
SERIM DISINTEK GTA 2.1%, MODEL: 5164
K083295
Serim Research Corp.
General Hospital · 126d
Cleared Sep 25, 2008
SERIM DISINTEK OPA TEST STRIP
K082352
Serim Research Corp.
General Hospital · 40d
Cleared Aug 22, 2008
STERIS RESERT XL TEST STRIP
K081600
STERIS Corporation
General Hospital · 77d