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
73–96 of 265
Cleared Oct 03, 2012
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518
Advanced Sterilization Products
General Hospital · 489d
Cleared Oct 03, 2012
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
K111519
Advanced Sterilization Products
General Hospital · 489d
Cleared Jun 04, 2012
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
K120435
STERIS Corporation
General Hospital · 112d
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 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 09, 2011
VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)
K102296
STERIS Corporation
General Hospital · 180d
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 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 Aug 07, 2009
VERIFY 275F GRAVITY INDICATORS
K083643
STERIS Corporation
General Hospital · 241d
Cleared Aug 22, 2008
STERIS RESERT XL TEST STRIP
K081600
STERIS Corporation
General Hospital · 77d
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 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 Dec 21, 2004
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482
STERIS Corporation
General Hospital · 4d