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
121–144 of 265
Cleared Jul 11, 2008
SERIM DISINTEK OPA TEST STRIP
K081370
Serim Research Corp.
General Hospital · 57d
Cleared Jun 11, 2008
BROWNE OPA TEST STRIP
K081427
STERIS Corporation
General Hospital · 21d
Cleared May 12, 2008
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
K080750
STERIS Corporation
General Hospital · 56d
Cleared Apr 30, 2008
EMU-GRAPH EMULATOR, MODEL CI 131
K072408
Steritec Products Mfg Co, Inc.
General Hospital · 247d
Cleared Jan 25, 2008
VERIFY CHALLENGE PACKS - VERSION 2
K073683
STERIS Corporation
General Hospital · 28d
Cleared Dec 11, 2007
VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
K072510
STERIS Corporation
General Hospital · 96d
Cleared Nov 14, 2007
VERIFY 275 DEGREE F. 3-10 INDICATOR
K071895
STERIS Corporation
General Hospital · 128d
Cleared Sep 05, 2007
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK
K070895
STERIS Corporation
General Hospital · 159d
Cleared Jul 17, 2007
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
K070461
STERIS Corporation
General Hospital · 151d
Cleared Jan 12, 2007
RELIANCE CI PROCESS INDICATOR
K063285
Albert Browne , Ltd.
General Hospital · 73d
Cleared Jan 05, 2007
STEAMPLUS STEAM INTEGRATOR
K063799
Spsmedical Supply Corp.
General Hospital · 14d
Cleared Aug 25, 2006
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
K061738
Albert Browne , Ltd.
General Hospital · 66d
Cleared Jul 18, 2006
VERIFY DRY HEAT LABEL
K053479
Albert Browne , Ltd.
General Hospital · 216d
Cleared Mar 24, 2006
VERIFY 3-10 MIN FLASH INTEGRATOR
K060066
Albert Browne , Ltd.
General Hospital · 74d
Cleared Mar 07, 2006
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
K060103
Albert Browne , Ltd.
General Hospital · 53d
Cleared Dec 06, 2005
VERIFY FLASH INTEGRATOR
K051101
Albert Browne , Ltd.
General Hospital · 221d
Cleared Dec 01, 2005
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388
Serim Research Corp.
General Hospital · 92d
Cleared Dec 21, 2004
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482
STERIS Corporation
General Hospital · 4d
Cleared Aug 17, 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152
Propper Mfg. Co., Inc.
General Hospital · 494d
Cleared Jun 25, 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017
Spsmedical Supply Corp.
General Hospital · 66d
Cleared Apr 02, 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742
Advanced Sterilization Products
General Hospital · 10d
Cleared Oct 17, 2003
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K032801
Albert Browne , Ltd.
General Hospital · 38d
Cleared May 09, 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680
Spsmedical Supply Corp.
General Hospital · 65d
Cleared Oct 08, 2002
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441
Advanced Sterilization Products
General Hospital · 75d