Product Code: JOJ FDA class 2 21 CFR 880.2800

Indicator, Physical/Chemical Sterilization Process

General Hospital

The Indicator, Physical/Chemical Sterilization Process is a general hospital device used to monitor and verify the effectiveness of physical or chemical sterilization processes, providing a visible or measurable change to indicate that sterilization conditions have been achieved for medical instruments and equipment. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence before marketing. It carries product code JOJ and is regulated under 21 CFR 880.2800, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

265

FEI Numbers

130

Registration Numbers

130

Unique Applicants

Years Active

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Basic Information

Product Code: JOJ
Device Class: FDA class 2
Regulation Number: 880.2800
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 265 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260181	LF Process Indicator Tape for Steam Sterilization	Feb 20, 2026	Substantially Equivalent	Intertape Polymer Group
K251991	SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)	Dec 23, 2025	Substantially Equivalent	Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
K251035	DISINTEK PA Test Strips	Jun 03, 2025	Substantially Equivalent	Serim Research
K251048	Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118	May 02, 2025	Substantially Equivalent	STERIS Corporation
K243876	VERIFY STEAM Integrating Indicator	Apr 25, 2025	Substantially Equivalent	STERIS Corporation
K250172	Green Card Bowie-Dick Test (BD115)	Feb 20, 2025	Substantially Equivalent	Steritec Products, Inc. (A Getinge Company)
K242860	Type 5 Integrating Indicator for Steam (CSPN-15)	Jan 17, 2025	Substantially Equivalent	True Indicating, LLC
K241036	Autoclave Indicator Tape; EO Indicator Tape	Dec 17, 2024	Substantially Equivalent	Jiangmen New Era External Use Drug Co., Ltd.
K243475	Chemical Indicator for enspire CLCSPS (LCC015)	Dec 04, 2024	Substantially Equivalent	STERIS Corporation
K242795	Getinge Assured MI Steam Migrating Integrator	Oct 15, 2024	Substantially Equivalent	Steritec Products Mfg. (A Getinge Group Company)
K241836	Kem Medical Lead-free Chemical Indicators for Steam Sterilization	Sep 30, 2024	Substantially Equivalent	Kem Medical Products Corporation
K242189	CELERITY HP Indicator Tape (PCC077)	Aug 20, 2024	Substantially Equivalent	Steris
K234084	STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)	Jul 05, 2024	Substantially Equivalent	Advanced Sterilization Products, Inc.
K233413	Ultraphon Chemical Indicator (TRO-T and TRO-B)	Jun 26, 2024	Substantially Equivalent	True Indicating, LLC
K240910	EO Chex Indicator Tape	Jun 12, 2024	Substantially Equivalent	Propper Manufacturing Co., Inc.
K241344	MetriCide OPA Plus Solution Test Strip	Jun 11, 2024	Substantially Equivalent	Steris
DEN230068	3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190	May 21, 2024	Unknown	3M Company
K240032	Celerity Chemical Indicator for enspire 3000 CLCSPS	Apr 17, 2024	Substantially Equivalent	STERIS Corporation
K240760	CELERITY HP Indicator Tape	Apr 10, 2024	Substantially Equivalent	Steris
K233654	VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems	Dec 08, 2023	Substantially Equivalent	Steris
K233187	Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)	Oct 27, 2023	Substantially Equivalent	Steris
K231488	Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape	Aug 07, 2023	Substantially Equivalent	Steris
K230558	Revital-Ox PAA High Level Disinfectant Chemical Indicator	Jul 17, 2023	Substantially Equivalent	STERIS Corporation
K222137	OK Plus Indicator	Dec 05, 2022	Substantially Equivalent	Propper Manufacturing Co., Inc.
K220778	Chemical Indicator for Steam	Dec 02, 2022	Substantially Equivalent	True Indicating, LLC
K222508	3M Comply Hydrogen Peroxide Chemical Indicator 1248	Nov 01, 2022	Substantially Equivalent	3M Company
K222152	3M Attest Hydrogen Peroxide Indicator Tape 1228	Sep 23, 2022	Substantially Equivalent	3M Company
K220942	3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)	Jun 24, 2022	Substantially Equivalent	3M Company
K220564	3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355	May 23, 2022	Substantially Equivalent	3M Company
K213412	VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM	Jan 21, 2022	Substantially Equivalent	Steris Corparation
K212592	Gas-Chex Indicator	Jan 20, 2022	Substantially Equivalent	Propper Manufacturing Co., Inc.
K212081	3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228	Sep 05, 2021	Substantially Equivalent	3M Company
K200096	Crosstex VH2O2 Chemical Indicators	Jul 15, 2021	Substantially Equivalent	Crosstex International, Inc. (A Cantel Medical Company)
K210866	Steri-Dot Process Indicator	Jun 21, 2021	Substantially Equivalent	Propper Manufacturing Co., Inc.
K210553	Steam-Dot Process Indicator	May 19, 2021	Substantially Equivalent	Propper Manufacturing Co., Inc.
K203458	3M Comply Hydrogen Peroxide Chemical Indicator 1248	Dec 11, 2020	Substantially Equivalent	3M Company
K203285	3M Comply Hydrogen Peroxide Indicator Tape 1228	Dec 10, 2020	Substantially Equivalent	3M Company
K202565	WAVICIDE-OPA MEC Indicator	Dec 02, 2020	Substantially Equivalent	Serim Research Corporation
K200334	AN1036 Dosimeter	Nov 12, 2020	Substantially Equivalent	Andersen Sterilizers, Inc.
K200272	Terragene Chemdye	Jun 30, 2020	Substantially Equivalent	Terragene S.A.
K200252	Getinge Assured MI Steam Migrating Integrator	May 21, 2020	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K192445	QwikCheck Chemical Indicators	Apr 02, 2020	Substantially Equivalent	Serim Research Corporation
K193254	3M Attest Steam Chemical Integrator	Dec 23, 2019	Substantially Equivalent	3M Company
K191236	3M Attest Steam Chemical Integrators	Nov 22, 2019	Substantially Equivalent	3M Company
K192937	3M Comply Hydrogen Peroxide Chemical Indicator	Nov 16, 2019	Substantially Equivalent	3M Company
K192673	3M Comply Hydrogen Peroxide Indicator Tape 1228	Oct 28, 2019	Substantially Equivalent	3M Company
K191999	Sterilucent VH2O2 Chemical Indicators	Oct 21, 2019	Substantially Equivalent	Sterilucent, Inc.
K192020	Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label	Sep 05, 2019	Substantially Equivalent	STERIS Corporation
K191741	Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape	Aug 02, 2019	Substantially Equivalent	Intertape Polymer, Inc.
K181788	Lead-free Chemical Indicators for Steam Sterilization	Mar 01, 2019	Substantially Equivalent	Kem Medical Products Corp.
K183211	3M Comply Hydrogen Peroxide Chemical Indicator	Feb 26, 2019	Substantially Equivalent	3M Company
K183209	3M Comply Hydrogen Peroxide Indicator Tape	Feb 15, 2019	Substantially Equivalent	3M Company
K183295	Celerity HP Chemical Indicator (CI)	Jan 04, 2019	Substantially Equivalent	Steris Corporations
K183293	VERIFY VH202 Indicator Tape	Jan 04, 2019	Substantially Equivalent	STERIS Corporation
K182724	CelerityTM 10 STEAM Chemical Indicator	Dec 10, 2018	Substantially Equivalent	STERIS Corporation
K173428	VERIFY Chemical Indicator for S40 Sterilant	Mar 02, 2018	Substantially Equivalent	STERIS Corporation
K171823	U&U Indicator tape and strip	Feb 22, 2018	Substantially Equivalent	U&U Medical Technology Co, Ltd.
K172753	VERIFY VH2O2 Indicator Tape	Feb 09, 2018	Substantially Equivalent	STERIS Corporation
K172746	VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label	Feb 09, 2018	Substantially Equivalent	STERIS Corporation
K172472	Micro-MEC 1.8% Glutaraldehyde Monitor Strip	Nov 17, 2017	Substantially Equivalent	STERIS Corporation
K170439	AN87 Dosimeter	Nov 01, 2017	Substantially Equivalent	Andersen Sterilizers, Inc.
K170426	AN85/AN86 EO Indicators	Oct 30, 2017	Substantially Equivalent	Andersen Sterilizers, Inc.
K170321	3M Comply Hydrogen Peroxide Chemical Indicator 1248	Aug 14, 2017	Substantially Equivalent	3M Company
K170563	3M Comply Hydrogen Peroxide Indicator Tape	Jul 27, 2017	Substantially Equivalent	3M Company
K162758	VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack	Mar 21, 2017	Substantially Equivalent	STERIS Corporation
K162631	VERIFY STEAM Integrating Indicator - Short	Jan 27, 2017	Substantially Equivalent	STERIS Corporation
K161024	Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape	Jun 28, 2016	Substantially Equivalent	Canadian Technical Tape, Ltd.
K160485	VERIFY VH2O2 Indicator Tape	Jun 01, 2016	Substantially Equivalent	STERIS Corporation
K152630	VERIFY STEAM Integrating Indicator	May 12, 2016	Substantially Equivalent	STERIS Corporation
K152394	Rapicide PA High-Level Disinfectant Test Strips	Mar 11, 2016	Substantially Equivalent	Medivators, Inc.
K150645	AN1087 Dosimeter	Nov 19, 2015	Substantially Equivalent	Andersen Sterilizers, Inc.
K150644	AN85/AN86 EO Indicators	Nov 18, 2015	Substantially Equivalent	Andersen Sterilizers, Inc.
K150694	3M Comply Hydrogen Peroxide Indicator Tape 1228	Oct 01, 2015	Substantially Equivalent	3M Company
K150622	3M Comply Hydrogen Peroxide Chemical Indicator 1248	Sep 29, 2015	Substantially Equivalent	3M Company
K150477	3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization	Jul 02, 2015	Substantially Equivalent	3M Company
K143520	SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)	Jun 09, 2015	Substantially Equivalent	Crosstex
K143629	U&U Bowie-Dick Test Pack	May 19, 2015	Substantially Equivalent	U&U Medical Technology Co, Ltd.
K143333	Revital-Ox RESERT Solution Test Strip	Apr 14, 2015	Substantially Equivalent	STERIS Corporation
K141698	STERIZONE CHEMICAL INDICATOR	Dec 17, 2014	Substantially Equivalent	Tso3, Inc.
K140566	SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE	Nov 24, 2014	Substantially Equivalent	Crosstex International
K140940	PROCESS INDICATOR TAPE FOR STEAM STERILIZATION	Oct 27, 2014	Substantially Equivalent	Canadian Technical Tape, Ltd.
K140515	VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL	Jul 17, 2014	Substantially Equivalent	STERIS Corporation
K132291	NAMSA CHEMICAL PROCESS	May 20, 2014	Substantially Equivalent	North American Science Assoc., Inc.
K133204	AIRVIEW MINI OWIE DICK TEST PACK	May 05, 2014	Substantially Equivalent	Crosstex International
K132372	STERITEC GREEN CARD PACK BOWIE-DICK TEST	Nov 26, 2013	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K130135	DANA REUSABLE BI TEST PACK	Nov 25, 2013	Substantially Equivalent	Dana Products, Inc.
K130160	VERIFY PROCESS INDICATOR FOR RELIANCE EPS	Aug 16, 2013	Substantially Equivalent	STERIS Corporation
K130211	AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS	Jul 05, 2013	Substantially Equivalent	Spsmedical Supply Corp.
K122945	STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126	Apr 30, 2013	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K120592	DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS	Feb 27, 2013	Substantially Equivalent	Dana Products, Inc.
K122555	STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE	Dec 12, 2012	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K120652	RAPICIDE OPA-28 TEST STRIP	Oct 12, 2012	Substantially Equivalent	Serim Research Corp.
K111519	STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202	Oct 03, 2012	Substantially Equivalent	Advanced Sterilization Products
K111518	STERRAD CHEMIAL INDICATOR STRIP MODEL 14100	Oct 03, 2012	Substantially Equivalent	Advanced Sterilization Products
K120435	BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR	Jun 04, 2012	Substantially Equivalent	STERIS Corporation
K111453	STEAM DOT BLU PROCESS INDICATOR	Apr 05, 2012	Substantially Equivalent	Propper Mfg. Co., Inc.
K112256	STERIS STEAM PI	Jan 11, 2012	Substantially Equivalent	STERIS Corporation
K103331	VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES	Sep 01, 2011	Substantially Equivalent	STERIS Corporation
K102894	CLASSIX CHEMICAL STERILIZATION INDICATOR	May 25, 2011	Substantially Equivalent	Propper Mfg. Co., Inc.
K110369	INDISTRIP GREEN	May 06, 2011	Substantially Equivalent	Indilab, Inc.
K110253	REUSABLE TEST PACK FOR DANA EMULATING INDICATORS	Apr 29, 2011	Substantially Equivalent	Dana Products, Inc.
K110152	SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS	Apr 15, 2011	Substantially Equivalent	Spsmedical Supply Corp.
K103219	STERRAD SEALSURE CHEMICAL INDICATOR TAPE	Apr 01, 2011	Substantially Equivalent	Advanced Sterilization Products
K103218	STERRAD CHEMICAL INDICATOR STRIP	Apr 01, 2011	Substantially Equivalent	Advanced Sterilization Products
K103053	VERIFY 270FP CHALLENGE PACK	Mar 10, 2011	Substantially Equivalent	STERIS Corporation
K103126	TROPHON CHEMICAL INDICATOR	Mar 03, 2011	Substantially Equivalent	Nanosonics Limited
K103000	SMART READ BIOLOGICAL TEST PACK	Feb 11, 2011	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K102296	VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)	Feb 09, 2011	Substantially Equivalent	STERIS Corporation
K102363	SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004	Jan 27, 2011	Substantially Equivalent	Spsmedical Supply Corp.
K100891	DANA EMULATING INDICATOR	Jan 13, 2011	Substantially Equivalent	Dana Products, Inc.
K102761	DANA REUSABLE TEST PACK FOR STEAM STERILIZATION	Dec 20, 2010	Substantially Equivalent	Dana Products, Inc.
K102217	SYSTEM 1E CHEMICAL INDICATOR	Nov 22, 2010	Substantially Equivalent	STERIS Corporation
K101528	3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM	Oct 01, 2010	Substantially Equivalent	3M Company
K101249	STERIGAGE MODEL 1243RA, 1243RB, 1243RE	Sep 08, 2010	Substantially Equivalent	3M Company
K101580	NEV'S INK AUTOCLAVE TAPES	Jul 01, 2010	Substantially Equivalent	Nev'S Ink, Inc.
K092346	SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171	Jan 07, 2010	Substantially Equivalent	Serim Research Corp.
K093199	3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK	Dec 04, 2009	Substantially Equivalent	3M Company
K091174	VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL	Oct 27, 2009	Substantially Equivalent	STERIS Corporation
K090650	SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS	Oct 09, 2009	Substantially Equivalent	Spsmedical Supply Corp.
K083643	VERIFY 275F GRAVITY INDICATORS	Aug 07, 2009	Substantially Equivalent	STERIS Corporation
K082620	ONCE-A-DAY VERTOS TEST PACK	Jul 08, 2009	Substantially Equivalent	Propper Mfg. Co., Inc.
K083295	SERIM DISINTEK GTA 2.1%, MODEL: 5164	Mar 16, 2009	Substantially Equivalent	Serim Research Corp.
K083650	EMU-GRAPH 4 EMULATOR, MODEL CI 144	Mar 05, 2009	Substantially Equivalent	Steritec Products, Inc.
K082352	SERIM DISINTEK OPA TEST STRIP	Sep 25, 2008	Substantially Equivalent	Serim Research Corp.
K081600	STERIS RESERT XL TEST STRIP	Aug 22, 2008	Substantially Equivalent	STERIS Corporation
K080136	INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105	Aug 15, 2008	Substantially Equivalent	Steritec Products, Inc.
K081370	SERIM DISINTEK OPA TEST STRIP	Jul 11, 2008	Substantially Equivalent	Serim Research Corp.
K081427	BROWNE OPA TEST STRIP	Jun 11, 2008	Substantially Equivalent	STERIS Corporation
K080750	BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR	May 12, 2008	Substantially Equivalent	STERIS Corporation
K080307	PROCHEM INDICATOR TAPE	May 01, 2008	Substantially Equivalent	Raven Laboratories
K072408	EMU-GRAPH EMULATOR, MODEL CI 131	Apr 30, 2008	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K073683	VERIFY CHALLENGE PACKS - VERSION 2	Jan 25, 2008	Substantially Equivalent	STERIS Corporation
K072510	VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2	Dec 11, 2007	Substantially Equivalent	STERIS Corporation
K071895	VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR	Nov 14, 2007	Substantially Equivalent	STERIS Corporation
K070895	VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK	Sep 05, 2007	Substantially Equivalent	STERIS Corporation
K070419	OPACIDEN OPA REAGENT STRIPS	Aug 31, 2007	Substantially Equivalent	Hach Company
K070461	VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4	Jul 17, 2007	Substantially Equivalent	STERIS Corporation
K062651	PROCHEM EXT CHEMICAL INTEGRATOR	Mar 15, 2007	Substantially Equivalent	Raven Biological Laboratories, Inc.
K063285	RELIANCE CI PROCESS INDICATOR	Jan 12, 2007	Substantially Equivalent	Albert Browne , Ltd.
K063799	STEAMPLUS STEAM INTEGRATOR	Jan 05, 2007	Substantially Equivalent	Spsmedical Supply Corp.
K061738	ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD	Aug 25, 2006	Substantially Equivalent	Albert Browne , Ltd.
K053479	VERIFY DRY HEAT LABEL	Jul 18, 2006	Substantially Equivalent	Albert Browne , Ltd.
K060066	VERIFY 3-10 MIN FLASH INTEGRATOR	Mar 24, 2006	Substantially Equivalent	Albert Browne , Ltd.
K060103	ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS	Mar 07, 2006	Substantially Equivalent	Albert Browne , Ltd.
K051101	VERIFY FLASH INTEGRATOR	Dec 06, 2005	Substantially Equivalent	Albert Browne , Ltd.
K052388	SERIM PERACETIC ACID CHEMICAL INDICATOR	Dec 01, 2005	Substantially Equivalent	Serim Research Corp.
K052516	STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137	Oct 03, 2005	Substantially Equivalent	Steritec Products, Inc.
K043482	THE RELIANCE PI PROCESS INDICATOR, MODEL D5116	Dec 21, 2004	Substantially Equivalent	STERIS Corporation
K040901	STERITEC EMU-GRAPH, MODEL NO. CI 131/US	Sep 09, 2004	Substantially Equivalent	Steritec Products, Inc.
K031152	PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)	Aug 17, 2004	Substantially Equivalent	Propper Mfg. Co., Inc.
K041017	SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK	Jun 25, 2004	Substantially Equivalent	Spsmedical Supply Corp.
K040742	MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE	Apr 02, 2004	Substantially Equivalent	Advanced Sterilization Products
K032801	MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR	Oct 17, 2003	Substantially Equivalent	Albert Browne , Ltd.
K021161	TSO3 OZONE CHEMICAL INDICATOR	Aug 27, 2003	Substantially Equivalent	Technologies of Sterilization With Oxone, Tso3, Inc.
K024293	BOWIE-DICK MINI PAK, MODEL BD 115	Aug 11, 2003	Substantially Equivalent	Steritec Products, Inc.
K031647	BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	Jul 29, 2003	Substantially Equivalent	Getinge USA, Inc.
K030680	SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR	May 09, 2003	Substantially Equivalent	Spsmedical Supply Corp.
K022441	STERRAD SEALSURE CHEMICAL INDICATOR TAPE	Oct 08, 2002	Substantially Equivalent	Advanced Sterilization Products
K020409	STEAMPLUS STERILIZATION TEST	Jul 18, 2002	Substantially Equivalent	Spsmedical Supply Corp.
K002741	BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK	Jul 03, 2002	Substantially Equivalent	Albert Browne , Ltd.
K020612	SULTAN SPOROX TEST VIAL, MODEL 75195	May 07, 2002	Substantially Equivalent	Sultan Chemists, Inc.
K012195	STEAM STERILIZATION INTERGRATOR	May 07, 2002	Substantially Equivalent	Dana Products, Inc.
K020589	3M COMPLY 1228 GAS PLASMA INDICATOR TAPE	Apr 22, 2002	Substantially Equivalent	3M Company
K012732	INTEGRAPH FLASH, MODEL CI 110	Mar 04, 2002	Substantially Equivalent	Steritec Products, Inc.
K013228	3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR	Jan 18, 2002	Substantially Equivalent	Minnesota Mining and Mfg. Co.
K012335	BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS	Oct 01, 2001	Substantially Equivalent	Albert Browne , Ltd.
K010534	CROSS-CHECKS DUAL, MODEL CI 125	Aug 06, 2001	Substantially Equivalent	Steritec Products, Inc.
K003533	CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L	Feb 07, 2001	Substantially Equivalent	Steritec Products, Inc.
K003002	STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123	Dec 08, 2000	Substantially Equivalent	Steritec Products, Inc.
K002861	EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124	Nov 29, 2000	Substantially Equivalent	Steritec Products, Inc.
K000355	3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR	Aug 23, 2000	Substantially Equivalent	Minnesota Mining and Mfg. Co.
K001649	STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234	Jun 23, 2000	Substantially Equivalent	Steritec Products, Inc.
K001444	STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103	May 15, 2000	Substantially Equivalent	Steritec Products, Inc.
K000502	STEAM/EO RECORD CARD, MODEL CI 121	Mar 14, 2000	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K992767	BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR	Jan 10, 2000	Substantially Equivalent	Albert Browne , Ltd.
K992341	CIDEX OPA SOLUTION TEST STRIP	Nov 23, 1999	Substantially Equivalent	Serim Research Corp.
K991709	BROWNE CIDEX OPA INDICATOR	Oct 08, 1999	Substantially Equivalent	Albert Browne , Ltd.
K991276	PASS/FAIL CHALLENGE PACK	Jul 12, 1999	Substantially Equivalent	Propper Mfg. Co., Inc.
K991418	BROWNE MVI ETHYLENE OXIDE INDICATOR	Jun 10, 1999	Substantially Equivalent	Albert Browne , Ltd.
K990246	STERI-PAK LF BOWIE-DICK TEST PACK	Jun 10, 1999	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K983451	CHALLENGE TEST PACK	Apr 23, 1999	Substantially Equivalent	North American Science Assoc., Inc.
K982151	STERITITE PROCESS INDICATOR ACCESSORIES	Feb 09, 1999	Substantially Equivalent	Case Medical, Inc.
K984616	BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION	Feb 04, 1999	Substantially Equivalent	Albert Browne , Ltd.
K984613	BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION	Feb 04, 1999	Substantially Equivalent	Albert Browne , Ltd.
K981054	BROWNE GA INDICATOR FOR CIDEX PRODUCTS	Dec 07, 1998	Substantially Equivalent	Albert Browne , Ltd.
K982188	STERI-PAK BOWIE DICK TEST PACK	Nov 20, 1998	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K973585	PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR	Nov 06, 1998	Substantially Equivalent	Propper Mfg. Co., Inc.
K982547	STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR	Oct 08, 1998	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K974415	KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP	Jul 10, 1998	Substantially Equivalent	Kimberly-Clark Corp.
K971971	BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK	Jul 10, 1998	Substantially Equivalent	Board of Directors, Albert Browne , Ltd.
K965212	STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM	Apr 23, 1998	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K972300	CROSS-CHECKS P	Mar 25, 1998	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K971369	BROWNE MVI STEAM INDICATOR	Jan 29, 1998	Substantially Equivalent	Albert Browne , Ltd.
K971888	GLUTATECT	Jan 09, 1998	Substantially Equivalent	Alden Scientific, Inc.
K972035	SPOROX TEST STRIPS	Aug 29, 1997	Substantially Equivalent	Serim Research Corp.
K970918	BROWNE STEAM INDICATOR	Jun 24, 1997	Substantially Equivalent	Board of Directors, Albert Browne , Ltd.
K960441	STERITEC INTEGRAPH MODEL CI-101	May 08, 1997	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K953122	STERITEC DRY HEAT INDICATOR LABEL	Apr 02, 1997	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K961156	ONCE-A-DAY BOWIE AND DICK TEST PACK.	Apr 01, 1997	Substantially Equivalent	Propper Mfg. Co., Inc.
K952244	CROSS-CHECKS EO GAS STERILIZATION MONITOR	Aug 05, 1996	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K960089	PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR	Apr 04, 1996	Substantially Equivalent	Cottrell, Ltd.
K955426	STERITEC CROSS-CHECKS	Mar 12, 1996	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K952995	ATI ETHYLENE OXIDE STERILIZATION INDICATOR	Feb 22, 1996	Substantially Equivalent	Pymah Corp.
K952408	ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION	Jul 06, 1995	Substantially Equivalent	Pymah Corp.
K951063	ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION	May 10, 1995	Substantially Equivalent	Pymah Corp.
K934066	NEPHRETECT	May 02, 1995	Substantially Equivalent	Alden Scientific, Inc.
K934874	STERIGAGE EO 100%	Apr 18, 1995	Substantially Equivalent	Pymah Corp.
K945190	STERRAD CHEMICAL INDICATOR TAPE	Dec 29, 1994	Substantially Equivalent	Advanced Sterilization Products
K932057	BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK	Aug 05, 1994	Substantially Equivalent	Board of Directors, Albert Browne , Ltd.
K922481	BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE	Jun 02, 1994	Substantially Equivalent	Board of Directors, Albert Browne , Ltd.
K932129	3M AUTOCLAVE TAPES	Mar 04, 1994	Substantially Equivalent	3M Company
K931935	ENDPOINT 500 PERACETIC ACID TEST INDICATORS	Feb 07, 1994	Substantially Equivalent	Minntech Corp.
K924681	GLUTARALDEHYDE MONITORS	Nov 17, 1993	Substantially Equivalent	Pymah Corp.
K921910	STERRAD CHEMICAL INDICATOR	Oct 04, 1993	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K922485	CHEMDI-VHP CHEMICAL INDICATOR	Sep 29, 1993	Substantially Equivalent	American Sterilizer Co.
K910320	SERIM PERACETIC ACID REAGENT STRIPS	May 01, 1991	Substantially Equivalent	Serim Research Corp.
K902958	TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE	Nov 01, 1990	Substantially Equivalent	Board of Directors, Albert Browne , Ltd.
K895910	STEAMLINE	Aug 22, 1990	Substantially Equivalent	Propper Mfg. Co., Inc.
K897045	BOWIE-DICK TEST CARD CATALOG NUMBER 008018	Feb 15, 1990	Substantially Equivalent	Edward Weck, Inc.
K895422	TOWER SELF SEAL STERILIZATION POUCH	Nov 29, 1989	Substantially Equivalent	Baxter Healthcare Corp
K890765	STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890764	LABEL, STERILIZATION INDICATOR; RADIATION	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890763	LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GAS	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890761	STRIP, STERILIZATION INDICATOR; DRY HEAT	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890760	STRIP, STERILIZATION INDICATOR, E.O. GAS	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890759	STRIP, STERILIZATION INDICATOR; STEAM	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890758	DRY HEAT STERILIZATION INDICATOR TAPE	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890757	C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K890755	SEALING TAPE, STERILIZATION INDICATOR; STEAM	Aug 07, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K882756	LANTOR CUBE STERILIZER TEST PACK	Oct 06, 1988	Substantially Equivalent	Lantor Group
K880548	SAFE-STRIPS	Sep 29, 1988	Substantially Equivalent	Medstar, Inc.
K875193	INDISTRIP (STERILIZATION PROCESS INDICATOR)	Mar 31, 1988	Substantially Equivalent	Indilab, Inc.
K851804	BIO-CHALLENGE TEST PAK	Jul 16, 1985	Substantially Equivalent	Propper Mfg. Co., Inc.
K851407	SURGICAL TOWELS	Jun 07, 1985	Substantially Equivalent	Diack
K844512	DART DAILY AIR REMOVAL TEST	Mar 21, 1985	Substantially Equivalent	American Sterilizer Co.
K843182	MASTER-CHEK BOWIE-DICK TYPE TEST	Oct 09, 1984	Substantially Equivalent	Arvey Corp.
K841168	STERILIZATION PROCESS INDICATOR	May 09, 1984	Substantially Equivalent	Parke-Davis Co.
K834353	OK FLASH STERILIZATION INDICATOR	Mar 19, 1984	Substantially Equivalent	Propper Mfg. Co., Inc.
K833074	CASTLE TEC-TEST S.M.A.R.T. PACK	Nov 07, 1983	Substantially Equivalent	Castle Co.
K833264	ADLER STEAM INDICATOR-GAS INDICATOR	Nov 03, 1983	Substantially Equivalent	Adler Instrument Co.
K831722	AC-22 AUTOCLAVE TAPE	Jul 06, 1983	Substantially Equivalent	Armak Tape Division
K823208	MYSTIK AUTOCLAVE TAPE	Dec 09, 1982	Substantially Equivalent	Mystik Corp.
K823074	CHEMDI STEAM & GAS STERILIZATION INDICA	Nov 08, 1982	Substantially Equivalent	American Sterilizer Co.
K823036	AUTOCLAVE TESTING ADHESIVE TAPE	Nov 08, 1982	Substantially Equivalent	Industrias Tuk, S.A. DE C.V.
K821997	MEDI + BIO SAFE STEAM STERILIZ. INDICAT	Aug 16, 1982	Substantially Equivalent	Arvey Corp.
K821648	GAS CHEX PLASTIC BAG	Jun 22, 1982	Substantially Equivalent	Propper Mfg. Co., Inc.
K820147	STERI-SHURE	Feb 05, 1982	Substantially Equivalent	General Health Systems, Inc.
K813202	THERMALOG S STEAM STERILIZATION INTEGRA	Dec 31, 1981	Substantially Equivalent	Bio-Medical Sciences, Inc.
K813014	PROTECT-O-SEAL	Nov 10, 1981	Substantially Equivalent	Tri-Med, Inc.
K812856	CHEMICAL INDICATORS	Nov 06, 1981	Substantially Equivalent	Sterilization Technical Services, Inc.
K811936	CHEMICAL AUTOCLAVE INDICATOR TAPE	Jul 28, 1981	Substantially Equivalent	American Hospital Supply Corp.
K810614	CASTLE STEAM STERILIZATION INDICATOR	Jun 24, 1981	Substantially Equivalent	Sybron Corp.
K811408	STERILIZATION INDICATOR/SEAL PROTECTOR	Jun 12, 1981	Substantially Equivalent	Beacon Converters, Inc.
K802634	STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.	Dec 11, 1980	Substantially Equivalent	Organon, Inc.
K802229	CHEMICAL INDICATOR - KEM MED & BIO SURE	Dec 09, 1980	Substantially Equivalent	Kem Medical Products Corp.
K801428	CHEMDI	Aug 13, 1980	Substantially Equivalent	American Sterilizer Co.
K801057	3M STEAM STERILIZATION INDICATOR	Jun 17, 1980	Substantially Equivalent	3M Company
K801109	PROOF (BIOLOGICAL/CHEMICAL INDICATOR)	May 30, 1980	Substantially Equivalent	Amsco Co.
K800873	TIME STEAM AUTOCLAVE TAPE	May 08, 1980	Substantially Equivalent	Professional Tape Co., Inc.
K792624	STERILIZATION PROCESS/ MAYO PAD	Jan 11, 1980	Substantially Equivalent	Procter & Gamble Mfg. Co.
K772358	ETHYLENE OXIDE STERILI. INDICATOR	Jan 30, 1978	Substantially Equivalent	Bio-Medical Sciences, Inc.
K772135	BIOLOGICAL/CHEMICAL INDICATOR	Dec 08, 1977	Substantially Equivalent	Amsco Co.
K771146	STEOILITY TESTING VESSEL	Aug 26, 1977	Substantially Equivalent	Tower Products, Inc.
K770078	CASTLE TEC-TEST STEAM STERI. INTEGRATOR	Feb 28, 1977	Substantially Equivalent	Castle Co.
K761011	CASTLE TEC-TEST AERATION MONITOR	Dec 02, 1976	Substantially Equivalent	Castle Co.