Product Code: FRC FDA class 2 21 CFR 880.2800

Indicator, Biological Sterilization Process

General Hospital

A biological sterilization process indicator is a device used to verify that sterilization procedures have been carried out effectively, typically containing spore-forming microorganisms that are killed only under proper sterilization conditions. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FRC, regulated under 21 CFR 880.2800, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

206

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FRC
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 206 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260766	Celerity 5 HP Biological Indicator (LCB052)	Apr 08, 2026	Substantially Equivalent	STERIS Corporation
K252680	Celerity 20 HP Biological Indicator	Sep 24, 2025	Substantially Equivalent	STERIS Corporation
K251122	Terragene® Bionova® BT20 Biological Indicator	Aug 04, 2025	Substantially Equivalent	Terragene
K251452	Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)	Jun 06, 2025	Substantially Equivalent	Steris
K250061	Celerity Incubator	Feb 06, 2025	Substantially Equivalent	STERIS Corporation
K250044	Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)	Feb 06, 2025	Substantially Equivalent	STERIS Corporation
K243501	3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	Jan 28, 2025	Substantially Equivalent	3M Company
K242453	Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)	Dec 12, 2024	Substantially Equivalent	Terragene S.A.
K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	Nov 25, 2024	Substantially Equivalent	3M Company
K241959	3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)	Oct 18, 2024	Substantially Equivalent	3M Company
K231383	Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)	Sep 18, 2024	Substantially Equivalent	Terragene S.A.
K241710	3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M	Sep 12, 2024	Substantially Equivalent	3M Company
K241542	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)	Jun 27, 2024	Substantially Equivalent	3M Company
K240717	3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E	Jun 27, 2024	Substantially Equivalent	3M Company
K233814	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)	Mar 15, 2024	Substantially Equivalent	3M Company
K233681	ConFirm 20 Minute Incubator	Dec 15, 2023	Substantially Equivalent	STERIS Corporation
K231490	Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator	Aug 07, 2023	Substantially Equivalent	STERIS Corporation
K223717	Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack	Jun 15, 2023	Substantially Equivalent	STERIS Corporation
K223715	Celerity Incubator	Jun 15, 2023	Substantially Equivalent	STERIS Corporation
K223023	Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)	May 09, 2023	Substantially Equivalent	Plasmapp Co,., Ltd.
K221641	Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)	Feb 28, 2023	Substantially Equivalent	Terragene S.A.
K213881	Celerity Incubator	Jul 21, 2022	Substantially Equivalent	STERIS Corporation
K211705	3M Attest Rapid Readout Biological Indicator, 1295	Jun 28, 2022	Substantially Equivalent	3M Company
K213296	Anprolene SteriTest RRBI	Apr 12, 2022	Substantially Equivalent	Andersen Sterilizers, Inc.
K213809	3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader	Apr 06, 2022	Substantially Equivalent	3M Company
K220473	CELERITY 20 HP Challenge Pack	Mar 18, 2022	Substantially Equivalent	Steris
K212193	Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)	Oct 22, 2021	Substantially Equivalent	Plasmapp Co,., Ltd.
K203560	STERIZONE VP4 Test Pack	Mar 24, 2021	Substantially Equivalent	Tso3 Inc., Now A Part of Stryker
K210277	3M Attest Rapid Readout Biological Indicator, 1295	Mar 03, 2021	Substantially Equivalent	3M Company
K202879	EOGas 4 Endo-SteriTest RRBI	Mar 03, 2021	Substantially Equivalent	Andersen Sterilizers, Inc.
K202721	Celerity 20 Steam Biological Indicator for IUSS	Jan 08, 2021	Substantially Equivalent	STERIS Corporation
K200970	Self-Contained Biological Indicator	Dec 28, 2020	Substantially Equivalent	True Indicating, LLC
K200996	3M Attest Rapid Readout Biological Indicator	Dec 11, 2020	Substantially Equivalent	3M Company
K192980	EOGas 4 Endo-SteriTest	Nov 12, 2020	Substantially Equivalent	Andersen Sterilizers, Inc.
K200766	3M Attest Steam Chemical Integrator Test Pack	Jul 02, 2020	Substantially Equivalent	3M Company
K192550	3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H	Jun 05, 2020	Substantially Equivalent	3M Company
K200536	3MTM AttestTM Rapid 5 Steam-Plus Test Pack	Jun 01, 2020	Substantially Equivalent	3M Complany
K200126	VERIFY Assert Self-Contained Biological Indicator	May 22, 2020	Substantially Equivalent	STERIS Corporation
K200092	3MTM AttestTM Mini Auto-reader 490M	Apr 15, 2020	Substantially Equivalent	3M
K193154	3M Attest Super Rapid 5 Steam-Plus Challenge Pack	Feb 07, 2020	Substantially Equivalent	3M Company
K192025	STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader	Jan 23, 2020	Substantially Equivalent	Advanced Sterilization Products (Asp)
K192001	Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device	Oct 22, 2019	Substantially Equivalent	Sterilucent, Inc.
K191021	Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye	Sep 13, 2019	Substantially Equivalent	Terragene S.A.
K190297	Celerity HP Incubator	May 14, 2019	Substantially Equivalent	STERIS Corporation
K183300	VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack	Jan 03, 2019	Substantially Equivalent	Steris Corporations
K183294	CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack	Jan 03, 2019	Substantially Equivalent	STERIS Corporation
K182404	STERRAD VELOCITY Biological Indicator	Dec 27, 2018	Substantially Equivalent	Advanced Sterilization Products (Asp)
K182931	VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag	Nov 20, 2018	Substantially Equivalent	Steris Corporations
K181434	SporView Rapid Read Biological Indicator SteamPlus Test Pack	Nov 14, 2018	Substantially Equivalent	Crosstex/Spsmedical, A Division of Cantel Medical
K181686	CELERITY 20 Steam Biological Indicator	Jul 24, 2018	Substantially Equivalent	STERIS Corporation
K181429	CELERITY 20 HP Biological Indicator	Jun 13, 2018	Substantially Equivalent	STERIS Corporation
K173519	3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader	Apr 23, 2018	Substantially Equivalent	3M Company
K173437	3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H	Mar 19, 2018	Substantially Equivalent	3M Company
K173488	CELERITY 20 HP Challenge Pack	Mar 01, 2018	Substantially Equivalent	STERIS Corporation
K173633	VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag	Feb 28, 2018	Substantially Equivalent	STERIS Corporation
K173629	CELERITY 20 Steam Process Challenge Device for Gravity Cycles	Feb 21, 2018	Substantially Equivalent	STERIS Corporation
K173626	Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles	Feb 21, 2018	Substantially Equivalent	STERIS Corporation
K173670	CELERITY 20 Steam Incubator	Feb 12, 2018	Substantially Equivalent	STERIS Corporation
K173634	CELERITY 20 Steam Biological Indicator	Feb 12, 2018	Substantially Equivalent	STERIS Corporation
K173435	3M Attest Rapid Readout Biological Indicator	Feb 09, 2018	Substantially Equivalent	3M Company
K172752	CELERITY 20 HP Biological Indicator	Feb 09, 2018	Substantially Equivalent	STERIS Corporation
K172748	VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack	Feb 09, 2018	Substantially Equivalent	Steris Corporations
K171287	Sporview VH202 BI	Feb 01, 2018	Substantially Equivalent	Spsmedical Supply Corp. A Division of Cantel Medical
K173584	3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader	Jan 22, 2018	Substantially Equivalent	3M Company
K172474	Celerity 20 HP Biological Indicator	Dec 29, 2017	Substantially Equivalent	STERIS Corporation
K172432	SporView Rapid Read Biological Indicator	Dec 12, 2017	Substantially Equivalent	Crosstex/Spsmedical, A Division of Cantel Medical
K163646	Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator	Nov 02, 2017	Substantially Equivalent	Terragene S.A.
K170427	Anprolene SteriTest	Oct 31, 2017	Substantially Equivalent	Andersen Sterilizers, Inc.
K171587	VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator	Aug 22, 2017	Substantially Equivalent	STERIS Corporation
K171504	VERIFY Assert VH2O2 Self-Contained Biological Indicator	Aug 22, 2017	Substantially Equivalent	STERIS Corporation
K171003	3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader	Jul 21, 2017	Substantially Equivalent	3M Company
K170039	STERRAD VELOCITY Biological Indictator and Reader	Jun 20, 2017	Substantially Equivalent	Advanced Sterilization Products (Asp)
K170070	VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles	Apr 28, 2017	Substantially Equivalent	STERIS Corporation
K163144	gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)	Apr 07, 2017	Substantially Equivalent	Gke-GmbH
K160546	3M Attest Rapid Readout Biological Indicator	Jun 09, 2016	Substantially Equivalent	3M Company
K151482	BCR-30-min BI and RBIP-ST30 Readout Accessory	Feb 26, 2016	Substantially Equivalent	Bcr Diagnostics, Inc.
K152060	3M Attest Rapid Readout Biological Indicator 1295	Dec 01, 2015	Substantially Equivalent	3M Company
K151585	Andersen EOGas 4 SteriTest	Nov 18, 2015	Substantially Equivalent	Andersen Sterilizers, Inc.
K151971	STERRAD CYCLESURE 24 Biological Indicator	Oct 29, 2015	Substantially Equivalent	Advanced Sterilization Products
K141580	STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR	Dec 17, 2014	Substantially Equivalent	Tso3, Inc.
K140589	STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR	Dec 03, 2014	Substantially Equivalent	Mesa Laboratories, Inc.
K141238	STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR	Nov 03, 2014	Substantially Equivalent	Sterilucent, Inc.
K141312	STERILUCENT PROCESS CHALLENGE DEVICE	Oct 31, 2014	Substantially Equivalent	Sterilucent, Inc.
K141244	NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)	Sep 09, 2014	Substantially Equivalent	North American Science Assoc., Inc.
K133549	STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	Aug 27, 2014	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K133322	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	Aug 25, 2014	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K140392	3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER	Aug 13, 2014	Substantially Equivalent	3M Company
K140620	SPORVIEW PLUS BI TEST PACK	Aug 07, 2014	Substantially Equivalent	Crosstex International
K140499	VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES	Jul 17, 2014	Substantially Equivalent	STERIS Corporation
K140708	VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR	Jun 16, 2014	Substantially Equivalent	STERIS Corporation
K130263	STERRAD 50/100S/200 TEST PACK	Mar 28, 2014	Substantially Equivalent	Advanced Sterilization Products
K133267	DANA REUSABLE TEST PACK	Feb 11, 2014	Substantially Equivalent	Dana Products, Inc.
K122024	SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR	Nov 26, 2013	Substantially Equivalent	Spsmedical Supply Corp.
K122362	SMART-WELL INCUBATOR	Mar 26, 2013	Substantially Equivalent	Mesa Laboratories, Inc.
K123546	3M ATTEST(TM) AUTO-READER	Mar 18, 2013	Substantially Equivalent	3M Company
K121593	3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK	Mar 15, 2013	Substantially Equivalent	3M Company
K123017	STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324	Dec 26, 2012	Substantially Equivalent	Advanced Sterilization Products
K121484	3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER	Oct 19, 2012	Substantially Equivalent	3M Company
K122044	STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR	Oct 04, 2012	Substantially Equivalent	Advanced Sterilization Products
K111391	STERRAD (R) 100NX DUO CYCLE TEST PACK	Sep 26, 2012	Substantially Equivalent	Advanced Sterilization Products
K111375	STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR	Sep 14, 2012	Substantially Equivalent	Advanced Sterilization Products
K113221	NAMSA BIOLOGICAL INDICATOR SPORE STRIPS	Apr 27, 2012	Substantially Equivalent	North American Science Assoc., Inc.
K111515	SPSMEDICAL SPORVIEW STEAM BI	Feb 01, 2012	Substantially Equivalent	Spsmedical Supply Corp.
K112018	SMART READ EZTEST STEAM	Jan 30, 2012	Substantially Equivalent	Mesa Laboratories, Inc.
K113302	NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS	Jan 20, 2012	Substantially Equivalent	North American Science Assoc., Inc.
K111150	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	Jul 08, 2011	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K103277	3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER	Apr 19, 2011	Substantially Equivalent	3M Company-3M Health Care
K103222	STERRAD CYCLESURE BIOLOGICAL INDICATOR	Feb 25, 2011	Substantially Equivalent	Advanced Sterilization Products
K092755	STERRAAD 100NX EXPRESS CYCLE TEST PACK	Feb 25, 2011	Substantially Equivalent	Advanced Sterilization Products
K103321	DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES	Feb 16, 2011	Substantially Equivalent	Dana Products, Inc.
K102884	STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR	Jan 28, 2011	Substantially Equivalent	Advanced Sterilization Products
K101910	3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS	Dec 08, 2010	Substantially Equivalent	3M Company
K093794	SMART-READ EZTEST-STEAM SCBI AND TEST PACK	May 14, 2010	Substantially Equivalent	Sgm Biotech, Inc.
K092944	DANA REUSABLE TEST PACK FOR STEAM STERILIZATION	Mar 18, 2010	Substantially Equivalent	Dana Products, Inc.
K091950	SMART-WELL EZTEST INCUBATOR	Jan 15, 2010	Substantially Equivalent	Sgm Biotech, Inc.
K092906	VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION	Dec 30, 2009	Substantially Equivalent	STERIS Corporation
K082756	RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR	Oct 21, 2009	Substantially Equivalent	Raven Biological Laboratories, Inc.
K083665	VERIFY SCBI 275F 3-10	Sep 01, 2009	Substantially Equivalent	STERIS Corporation
K090569	MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292	Apr 29, 2009	Substantially Equivalent	3M Company
K090514	VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES	Mar 16, 2009	Substantially Equivalent	STERIS Corporation
K073618	VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK	Jan 07, 2009	Substantially Equivalent	STERIS Corporation
K073244	VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES	May 28, 2008	Substantially Equivalent	STERIS Corporation
K071537	STERRAD 100NX TEST PACK	Dec 18, 2007	Substantially Equivalent	Advanced Sterilization Products
K071014	MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR	May 24, 2007	Substantially Equivalent	Advanced Sterilization Products
K070595	SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR	May 24, 2007	Substantially Equivalent	Spsmedical Supply Corp.
K051056	VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR	Oct 20, 2005	Substantially Equivalent	Albert Browne , Ltd.
K051643	STERRAD STERILIZER CYCLESURE TEST PACK	Aug 19, 2005	Substantially Equivalent	Advanced Sterilization Products
K052128	3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER	Aug 16, 2005	Substantially Equivalent	3M Company
K051173	SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK	May 27, 2005	Substantially Equivalent	Spsmedical Supply Corp.
K042450	STERRAD NX CHALLENGE PACK	May 12, 2005	Substantially Equivalent	Advanced Sterilization Products
K050664	SPOR-TEST PA BIOLOGICAL INDICATOR KIT	Apr 07, 2005	Substantially Equivalent	Getinge USA, Inc.
K050591	MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS	Mar 23, 2005	Substantially Equivalent	Raven Biological Laboratories, Inc.
K041784	RAVEN PROTEST - EO	Sep 13, 2004	Substantially Equivalent	Raven Biological Laboratories, Inc.
K041386	RAVEN PROTEST - STEAM	Aug 09, 2004	Substantially Equivalent	Raven Biological Laboratories, Inc.
K032914	MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS	May 25, 2004	Substantially Equivalent	Raven Biological Laboratories, Inc.
K041099	MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP	May 06, 2004	Substantially Equivalent	Spsmedical Supply Corp.
K031012	ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK	Oct 16, 2003	Substantially Equivalent	3M Company
K032723	BIOSIGN STEAM-24 BIOLOGICAL INDICATOR	Oct 01, 2003	Substantially Equivalent	Getinge USA, Inc.
K031226	STERRAD CYCLESURE BIOLOGICAL INDICATOR	May 02, 2003	Substantially Equivalent	Advanced Sterilization Products
K024079	ALIBI BIOLOGICAL INDICATOR, MODEL WS	Feb 27, 2003	Substantially Equivalent	Arden Laboratories, Incorporated
K023716	SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP	Dec 05, 2002	Substantially Equivalent	Spsmedical Supply Corp.
K022706	SPSMEDICAL SPORVIEW STEAM BI TEST PACK	Oct 25, 2002	Substantially Equivalent	Spsmedical Supply Corp.
K020205	CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT	Jun 24, 2002	Substantially Equivalent	Getinge/Castle, Inc.
K004009	3M ATTEST 290 AUTO-READER	Mar 25, 2002	Substantially Equivalent	3M Company
K994055	STERRAD CYCLESURE BIOLOGICAL INDICATOR	Feb 13, 2002	Substantially Equivalent	Advanced Sterilization Products
K020026	RAVEN BACTERIAL SPORE STRIPS	Jan 30, 2002	Substantially Equivalent	Raven Biological Laboratories, Inc.
K994381	PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR	Mar 30, 2001	Substantially Equivalent	Raven Biological Laboratories, Inc.
K991618	BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR	Jan 24, 2001	Substantially Equivalent	Propper Mfg. Co., Inc.
K993775	STERRAD BI TEST PACK	Jun 01, 2000	Substantially Equivalent	Advanced Sterilization Products
K991675	MODIFICATION OF: STERRAD BI TEST PACK	Jun 15, 1999	Substantially Equivalent	Advanced Sterilization Products
K981497	STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS	Oct 29, 1998	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K972747	BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)	Jan 09, 1998	Substantially Equivalent	Propper Mfg. Co., Inc.
K971430	PROSPORE II	May 22, 1997	Substantially Equivalent	Raven Biological Laboratories, Inc.
K971432	PROSPORE	May 20, 1997	Substantially Equivalent	Raven Biological Laboratories, Inc.
K930683	EZTEST-GAS	Mar 04, 1997	Substantially Equivalent	Sgm Biomedical, Inc.
K963841	EZTEST	Feb 25, 1997	Substantially Equivalent	Sgm Biotech, Inc.
K962441	PROSPORE(STEARO FOR STEAM STERILIZER)	Sep 18, 1996	Substantially Equivalent	Raven Biological Laboratories, Inc.
K961721	STERITEC DISPOSABLE BIOLOGICAL TEST PACK	Aug 23, 1996	Substantially Equivalent	Steritec Products Mfg Co, Inc.
K960790	PROSPORE II	Aug 16, 1996	Substantially Equivalent	Raven Biological Laboratories, Inc.
K960777	MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR	May 23, 1996	Substantially Equivalent	Mdt Corp., Inc.
K926364	ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X	Mar 31, 1995	Substantially Equivalent	3M Health Care, Ltd.
K923739	ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR	Dec 22, 1994	Substantially Equivalent	Abtox, Inc.
K930682	EZTEST-STEAM	Apr 04, 1994	Substantially Equivalent	Sgm Biotech, Inc.
K925745	ATI(R) DISP BIOLOGICAL-PLUS TEST PACK	Feb 01, 1994	Substantially Equivalent	Pymah Corp.
K925496	ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK	Feb 01, 1994	Substantially Equivalent	Pymah Corp.
K921909	STERRAD BI TEST PACK	Oct 01, 1993	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K922212	MDT CASTLE BIOSIGN TEST PACK	Aug 10, 1992	Substantially Equivalent	Mdt Corp., Inc.
K912796	SPORE STRIP	Apr 02, 1992	Substantially Equivalent	Raven Biological Laboratories, Inc.
K905425	SPORVIEW	Mar 27, 1992	Substantially Equivalent	Spsmedical Supply Corp.
K910417	EVIDENCE BIOLOGICAL INDICATOR	Mar 08, 1991	Substantially Equivalent	Skyland Scientific Services, Inc.
K903024	BI-O.K. STEAM TEST-PAK	Sep 12, 1990	Substantially Equivalent	Propper Mfg. Co., Inc.
K902344	ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER	Jul 19, 1990	Substantially Equivalent	Ati
K900771	ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR	Jul 03, 1990	Substantially Equivalent	3M Company
K895704	ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE	Mar 08, 1990	Substantially Equivalent	Pymah Corp., Ati Div.
K891784	BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR	Feb 09, 1990	Substantially Equivalent	Propper Mfg. Co., Inc.
K890754	SPORVIEW CULTURE MEDIA	Nov 17, 1989	Substantially Equivalent	Spsmedical Supply Corp.
K894399	STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.	Sep 11, 1989	Substantially Equivalent	Pymah Corp.
K894398	STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE	Sep 11, 1989	Substantially Equivalent	Pymah Corp.
K891366	BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)	Mar 29, 1989	Substantially Equivalent	Mdt Corp., Inc.
K884615	ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK	Jan 19, 1989	Substantially Equivalent	Pymah Corp., Ati Div.
K884767	ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK	Jan 10, 1989	Substantially Equivalent	Pymah Corp., Ati Div.
K872867	BIOSIGN	Jul 06, 1988	Substantially Equivalent	Clinical Technology Corp.
K863122	ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.	Dec 17, 1986	Substantially Equivalent	Surgicot, Inc.
K855101	ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR	Jul 17, 1986	Substantially Equivalent	Surgicot, Inc.
K855120	ATI DISPOSABLE BIOLOGICAL TEST PACK	Jun 18, 1986	Substantially Equivalent	Parke-Davis Co.
K854631	ASSERT EO BIOLOGICAL TEST PACK	May 27, 1986	Substantially Equivalent	Surgicot, Inc.
K854902	SURGICOT STEAM TEST PACK	May 20, 1986	Substantially Equivalent	Surgicot, Inc.
K844479	CHEMSPOR	Nov 25, 1985	Substantially Equivalent for Some Indications	American Sterilizer Co.
K852192	DISPOSABLE STEAM BIOLOGICAL TEST PACK	Nov 01, 1985	Substantially Equivalent	Parke-Davis Co.
K850144	BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH	Jun 17, 1985	Substantially Equivalent	American Sterilizer Co.
K841709	48 HOUR BIOLOGICAL INDICATORS SPORSTRIP	Oct 02, 1984	Substantially Equivalent	Skyland Scientific Services, Inc.
K841583	SPORSTRIP	May 25, 1984	Substantially Equivalent	Skyland Scientific Services, Inc.
K832922	TRAVASPORE BIOLOGICAL INDICATOR	Nov 21, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K822024	BACILLU S SUBTILIS BIOLOGICAL INDICA.	Jul 22, 1982	Substantially Equivalent	Findley Research, Inc.
K812272	CASTLE TEC-TEST BIOLOGICAL INDICATOR	Sep 08, 1981	Substantially Equivalent	Sybron Corp.
K810930	BACILLUM PUMILUS SPORE STRIPS	Jun 16, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K802228	BIOLOGICAL INDICATOR - KEMMED & BIOSURE	Dec 09, 1980	Substantially Equivalent	Kem Medical Products Corp.
K801678	SPOR-TEST-STRIP	Aug 13, 1980	Substantially Equivalent	Sterilization Technical Services, Inc.
K800482	STEAROTHERMOHILUS SPORE STRIPS	Apr 16, 1980	Substantially Equivalent	Mdt Corp., Inc.
K800029	SURGICOT 2 INDICATOR SYSTEM	Mar 12, 1980	Substantially Equivalent	Surgicot, Inc.
K792648	UNILAB CULTURING SET	Feb 06, 1980	Substantially Equivalent	Sybron Corp.
K792649	UNISPORE-BIOLOGICAL INDICATORS	Jan 29, 1980	Substantially Equivalent	Castle Co.
K771132	KENWOOD BIOLOGICAL STEOILIZ. INDICATOR	Jul 14, 1977	Substantially Equivalent	Will Ross Co.
K771080	STEAM STERILIZATION INDICATOR	Jul 14, 1977	Substantially Equivalent	Info-Chem
K770953	MONITOR, AERATION, TEC-TEST	Jul 14, 1977	Substantially Equivalent	Castle Co.
K761015	MARKET CASTLE UNISPHERE	Jan 21, 1977	Substantially Equivalent	Castle Co.