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
73–96 of 265
Cleared Oct 01, 2015
3M Comply Hydrogen Peroxide Indicator Tape 1228
K150694
3M Company
General Hospital · 197d
Cleared Sep 29, 2015
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K150622
3M Company
General Hospital · 202d
Cleared Jul 02, 2015
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
K150477
3M Company
General Hospital · 128d
Cleared Jun 09, 2015
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)
K143520
Crosstex
General Hospital · 179d
Cleared May 19, 2015
U&U Bowie-Dick Test Pack
K143629
U&U Medical Technology Co, Ltd.
General Hospital · 148d
Cleared Apr 14, 2015
Revital-Ox RESERT Solution Test Strip
K143333
STERIS Corporation
General Hospital · 145d
Cleared Dec 17, 2014
STERIZONE CHEMICAL INDICATOR
K141698
Tso3, Inc.
General Hospital · 176d
Cleared Nov 24, 2014
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
K140566
Crosstex International
General Hospital · 264d
Cleared Oct 27, 2014
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
K140940
Canadian Technical Tape, Ltd.
General Hospital · 196d
Cleared Jul 17, 2014
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
K140515
STERIS Corporation
General Hospital · 139d
Cleared May 20, 2014
NAMSA CHEMICAL PROCESS
K132291
North American Science Assoc., Inc.
General Hospital · 301d
Cleared May 05, 2014
AIRVIEW MINI OWIE DICK TEST PACK
K133204
Crosstex International
General Hospital · 200d
Cleared Nov 26, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372
Steritec Products Mfg Co, Inc.
General Hospital · 119d
Cleared Nov 25, 2013
DANA REUSABLE BI TEST PACK
K130135
Dana Products, Inc.
General Hospital · 311d
Cleared Aug 16, 2013
VERIFY PROCESS INDICATOR FOR RELIANCE EPS
K130160
STERIS Corporation
General Hospital · 205d
Cleared Jul 05, 2013
AIRVIEW BOWIE DICK
K130211
Spsmedical Supply Corp.
General Hospital · 157d
Cleared Apr 30, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
K122945
Steritec Products Mfg Co, Inc.
General Hospital · 218d
Cleared Feb 27, 2013
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
K120592
Dana Products, Inc.
General Hospital · 365d
Cleared Dec 12, 2012
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
K122555
Steritec Products Mfg Co, Inc.
General Hospital · 112d
Cleared Oct 12, 2012
RAPICIDE OPA-28 TEST STRIP
K120652
Serim Research Corp.
General Hospital · 224d
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 Apr 05, 2012
STEAM DOT BLU PROCESS INDICATOR
K111453
Propper Mfg. Co., Inc.
General Hospital · 316d