Product Code: FLE FDA class 2 21 CFR 880.6880

Sterilizer, Steam

General Hospital

The Steam Sterilizer is a hospital device that uses pressurized saturated steam to sterilize medical instruments and equipment, eliminating microorganisms to prevent infection. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLE, regulated under 21 CFR 880.6880 in the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

180

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: FLE
Device Class: FDA class 2
Regulation Number: 880.6880
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 180 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243994	Steam Sterilizer (2545D)	Jun 06, 2025	Substantially Equivalent	Ningbo Ican Machines Co., Ltd.
K243801	FRONT-LINE Field Sterilizer (FL135)	Mar 07, 2025	Substantially Equivalent	Fort Defiance Industries LLC
K233026	Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer	Apr 04, 2024	Substantially Equivalent	Midmark Corporation
K233504	Lexa MINI (RIS-303, RIS-305)	Feb 08, 2024	Substantially Equivalent	W&H Sterilization S.r.l.
K233132	PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)	Dec 19, 2023	Substantially Equivalent	PRIMUS Sterilizer Company, LLC
K232658	T-Top 10 & T-Top T-Top 11	Nov 27, 2023	Substantially Equivalent	Tuttnauer U.S.A Co, Ltd
K232485	AMSCO 600 Steam Sterilizer	Sep 13, 2023	Substantially Equivalent	Steris
K231489	Sturdy Autoclave Super Microm	Jun 21, 2023	Substantially Equivalent	Sturdy Industrial Co., Ltd
K223858	Lexa MINI (RIS-303, RIS-305)	May 05, 2023	Substantially Equivalent	W&H Sterilization S.r.l.
K221474	PRIMUS Healthcare Sterilizer (Model PSS11-HC)	Feb 10, 2023	Substantially Equivalent	PRIMUS Sterilizer Company, LLC
K213545	Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869	Feb 02, 2023	Substantially Equivalent	Steelco S.P.A.
K222608	Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS	Dec 16, 2022	Substantially Equivalent	Tuttnauer LTD.
K220102	MOST-T Autoclave	Oct 12, 2022	Substantially Equivalent	Shinva Medical Instrument Co., Ltd.
K221227	Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120	Sep 20, 2022	Substantially Equivalent	Tuttnauer Ltd.
K213758	Lexa PLUS RIS-311	Aug 19, 2022	Substantially Equivalent	W&H Sterilization s.r.l.
K220736	Consolidated HC Steam Sterilizer	Aug 01, 2022	Substantially Equivalent	Consolidated Machine Corp.
K214120	GSS610N21 Series Steam Sterilizer	May 18, 2022	Substantially Equivalent	Maquet GmbH
K214057	STATIM 6000B Vacuum Autoclave	Mar 31, 2022	Substantially Equivalent	SciCan Ltd.
K213457	Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135	Mar 02, 2022	Substantially Equivalent	Fort Defiance Industries LLC
K213991	Enbio S	Feb 22, 2022	Substantially Equivalent	Enbio Group AG
K213080	T-Edge 10, T-Edge 11	Jan 04, 2022	Substantially Equivalent	Tuttnauer Ltd.
K210279	Enbio S	Oct 29, 2021	Substantially Equivalent	Enbio Group AG
K212424	AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers	Oct 28, 2021	Substantially Equivalent	STERIS Corporation
K211500	AMSCO 600 Medium Steam Sterilizer	Aug 25, 2021	Substantially Equivalent	Steris Corporation
K210326	Bravo G4 Chamber Autoclave	Jul 01, 2021	Substantially Equivalent	SciCan Ltd.
K201927	Getinge GSS610N Series Steam Sterilizer	Mar 01, 2021	Substantially Equivalent	Maquet GmbH
K203061	Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)	Nov 06, 2020	Substantially Equivalent	STERIS Corporation
K192910	STATClave G4 Chamber Autoclave	Jun 19, 2020	Substantially Equivalent	SciCan Ltd.
K181993	STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)	Nov 01, 2019	Substantially Equivalent	Sturdy Industrial Co., Ltd
K191896	Belimed Steam Sterilizer MST-H TOP 5000	Oct 31, 2019	Substantially Equivalent	Belimed AG
K190062	STATCLAVE G4 Chamber Autoclave	Jul 26, 2019	Substantially Equivalent	SciCan Ltd.
K181456	Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves	Jul 08, 2019	Substantially Equivalent	Tuttnauer Ltd.
K183410	AMSCO 600 Steam Sterilizer	Mar 27, 2019	Substantially Equivalent	STERIS Corporation
K180272	Saniclave 250	Jul 26, 2018	Substantially Equivalent	REVOLUTIONARY SCIENCE
K172825	MN-111	May 30, 2018	Substantially Equivalent	W&H Sterilization s.r.l.
K173481	Amsco Evolution Medium Steam Sterilizer	Mar 09, 2018	Substantially Equivalent	STERIS Corporation
K170304	Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers	Mar 02, 2018	Substantially Equivalent	Astell Scientific Limited
K173493	Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000	Feb 23, 2018	Substantially Equivalent	STERIS Corporation
K173490	Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)	Feb 22, 2018	Substantially Equivalent	STERIS Corporation
K173485	Amsco Evolution Medium Steam Sterilizer	Feb 22, 2018	Substantially Equivalent	STERIS Corporation
K172159	Getinge GSS67N Series Steam Sterilizer	Jan 30, 2018	Substantially Equivalent	Maquet GmbH
K163337	Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer	Aug 31, 2017	Substantially Equivalent	Midmark Corporation
K170228	Belimed Steam Sterilizer MST-H TOP 5000	May 12, 2017	Substantially Equivalent	Belimed AG
K161848	Family of Steam sterilizers B17 B22 Series	Feb 23, 2017	Substantially Equivalent	CEFLA S.C.
K151597	Family of Steam Sterilizers B 28 series	Mar 04, 2016	Substantially Equivalent	CEFLA S.C.
K141879	BELIMED STEAM STERILIZER MST-H	Jun 17, 2015	Substantially Equivalent	SAUTER AG
K140736	STERISAFE HP TABLE-TOP STEAM STERILIZER	Jan 20, 2015	Substantially Equivalent	MILTON E PEDRAZZI D.D.S., INC.
K143311	Pre-vacuum Tabletop Autoclave	Jan 15, 2015	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K141009	FORT DEFIANCE AUTOMATED STEAM STERILIZER	Dec 16, 2014	Substantially Equivalent	Fort Defiance Industries, Inc.
K132439	SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER	Jan 06, 2014	Substantially Equivalent	SAKURA SEIKI CO., LTD.
K130172	BELIMED STEAM STERILIZER MST-V	Sep 23, 2013	Substantially Equivalent	BELIMED, INC.
K122978	SANICLAVE 102, MODEL RS-SC-102	May 23, 2013	Substantially Equivalent	ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
K122625	GETINGE 800HC- SERIES STEAM STERILIZER	May 22, 2013	Substantially Equivalent	GETINGE SOURCING LLC
K122774	SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG	May 09, 2013	Substantially Equivalent	SAKURA SEIKI CO., LTD.
K122071	GETINGE 400HC-E / SERIES STEAM STERILIZER	Mar 12, 2013	Substantially Equivalent	GETINGE SOURCING LLC
K112872	STATIM 2000 G4 CASSETTE	Jul 10, 2012	Substantially Equivalent	SCICAN LTD.
K120441	GETINGE 700HC-E SERIES STEAM STERILIZER	May 31, 2012	Substantially Equivalent	GETINGE SOURCING LLC
K120149	SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA	May 08, 2012	Substantially Equivalent	SAKURA SEIKI CO., LTD.
K112403	AMSCO CHIMERON MEDIUM STEAM STERLILZER	May 08, 2012	Substantially Equivalent	STERIS Corporation
K112811	SANICLAVE 200	Jan 11, 2012	Substantially Equivalent	ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
K112055	AMSCO CHIMERON MEDIUM STEAM STERILIZER	Dec 16, 2011	Substantially Equivalent	STERIS Corporation
K111736	TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES	Dec 08, 2011	Substantially Equivalent	TUTTNAUER CO. LTD.
K111223	AMSCO CHIMERON SMALL STEAM STERILIZER	Sep 20, 2011	Substantially Equivalent	STERIS Corporation
K103504	GETINGE 400HC/500HC SERIES STEAM STERILIZER	Mar 16, 2011	Substantially Equivalent	GETINGE SOURCING, LLC
K103841	BELIMED STEAM STERILIZER MST-V	Mar 15, 2011	Substantially Equivalent	SAUTER AG
K100622	BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6	Aug 27, 2010	Substantially Equivalent	BELIMED SAUTER AG
K093333	PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8	Apr 02, 2010	Substantially Equivalent	PRIMUS STERILIZER COMPANY, LLC.
K092490	AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000	Nov 04, 2009	Substantially Equivalent	STERIS Corporation
K090339	BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2	Sep 23, 2009	Substantially Equivalent	BELIMED SAUTER AG
K091731	AMSCO EVOLUTION MEDIUM STEAM STERILIZER	Sep 17, 2009	Substantially Equivalent	STERIS Corporation
K090783	TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE	Aug 20, 2009	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K090670	MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER	Jul 07, 2009	Substantially Equivalent	MIDMARK CORP.
K091136	AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200	Jun 29, 2009	Substantially Equivalent	STERIS Corporation
K082817	PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M	May 21, 2009	Substantially Equivalent	PRIMUS STERILIZER COMPANY, LLC.
K090265	BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V	May 15, 2009	Substantially Equivalent	SCICAN LTD.
K082435	AMSCO EVOLUTION MEDIUM STEAM STERILIZER	Dec 30, 2008	Substantially Equivalent	STERIS Corporation
K072466	STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101	Dec 19, 2007	Substantially Equivalent	SCICAN LTD.
K072087	BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24	Oct 05, 2007	Substantially Equivalent	BELIMED SAUTER AG
K063681	TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE	Jun 29, 2007	Substantially Equivalent	MEDILINE ITALIA S.R.L.
K070657	GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER	Apr 05, 2007	Substantially Equivalent	GETINGE SOURCING LLC
K063711	TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA	Feb 02, 2007	Substantially Equivalent	TUTTNAUER CO. LTD.
K050263	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	Nov 21, 2006	Substantially Equivalent	M.O.C.O.M. SRL
K052532	IMAX 9.5 STERILIZERS	Sep 05, 2006	Substantially Equivalent	DENTAL X SRL
K060337	BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9	Mar 08, 2006	Substantially Equivalent	SAUTER AG
K041833	CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER	Dec 10, 2004	Substantially Equivalent	CONSOLIDATED MACHINE CORP.
K032192	PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V	Aug 12, 2004	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K033538	BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8	Feb 02, 2004	Substantially Equivalent	SAUTER AG
K024133	CLS-2000 UNIT	Oct 01, 2003	Substantially Equivalent	DENTSPLY INTL.
K031259	MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER	May 12, 2003	Substantially Equivalent	GETINGE USA, INC
K030789	AMSCO CENTURY STEAM STERILIZER	Mar 26, 2003	Substantially Equivalent	STERIS Corporation
K023348	MIDMARK M9 ULTRACLAVE STEAM STERILIZER	Mar 03, 2003	Substantially Equivalent	MIDMARK CORP.
K022816	W & H LISA STEAM STERILIZER	Feb 07, 2003	Substantially Equivalent	A-DEC, INC.
K021064	QUANTIM 16 AUTOCLAVE	Aug 08, 2002	Substantially Equivalent	SCICAN
K021504	TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540	Jul 25, 2002	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K021223	BELIMED STEAM STERILIZER, MODEL TOP 5000	Jun 26, 2002	Substantially Equivalent	SAUTER AG
K020747	AMSCO CENTURY MEDIUM STERILIZER 26 X 26	May 17, 2002	Substantially Equivalent	STERIS Corporation
K020590	MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER	Mar 20, 2002	Substantially Equivalent	GETINGE/CASTLE, INC.
K014174	HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33	Feb 22, 2002	Substantially Equivalent	BARNSTEAD/THERMOLYNE CORP.
K012573	CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC	Sep 05, 2001	Substantially Equivalent	GETINGE/CASTLE, INC.
K010865	AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY	May 31, 2001	Substantially Equivalent	STERIS Corporation
K003470	EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870	Feb 20, 2001	Substantially Equivalent	TUTTNAUER CO. LTD.
K993856	TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP	Feb 09, 2001	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K003441	CASTLE MODEL 233HC STEAM STERILIZER	Jan 02, 2001	Substantially Equivalent	GETINGE/CASTLE, INC.
K000077	STERIS AMSCO MILLENNIUM STEAM STERILIZER	Mar 17, 2000	Substantially Equivalent	STERIS Corporation
K994314	CASTLE SERIES 100HC STEAM STERILIZERS	Feb 16, 2000	Substantially Equivalent	GETINGE/CASTLE, INC.
K992744	MIDMARK M4*9 EASYCLAVE STEAM STERILIZER	Jan 10, 2000	Substantially Equivalent	MIDMARK CORP.
K991575	PRIMUS STEAM STERILIZERS	Dec 03, 1999	Substantially Equivalent	PRIMUS STERILIZER CO., INC.
K990189	MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER	Apr 19, 1999	Substantially Equivalent	MIDMARK CORP.
K982332	STERIS TEN SIXTEEN STEAM STERILIZER	Jan 20, 1999	Substantially Equivalent	STERIS Corporation
K983679	STATIM 5000 CASSETTE AUTOCLAVE	Jan 04, 1999	Substantially Equivalent	SCICAN
K964332	EAGLE CENTURY STEAM STERILIZER	Jun 01, 1998	Substantially Equivalent	AMSCO INTL., INC.
K980014	THE SYSTEM 2S STEAM STERILIZER	May 15, 1998	Substantially Equivalent	STERIS Corporation
K962903	PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE	Mar 03, 1998	Substantially Equivalent	PRESTIGE MEDICAL CORP.
K973225	CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)	Feb 10, 1998	Substantially Equivalent	GETINGE/CASTLE, INC.
K970907	CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)	Nov 12, 1997	Substantially Equivalent	GETINGE/CASTLE, INC.
K962282	TUTTNAUER PREVACUUM TABLE AUTOCLAVE	Nov 12, 1997	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K973550	TUTTNAUER TABLE-TOP AUTOCLAVE	Oct 29, 1997	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K954142	STERRADD STERILIZATION SYSTEM	Jun 06, 1997	Substantially Equivalent	ADVANCED STERILIZATION PRODUCTS
K962755	STRYKER ENCORE STERILIZER	Mar 04, 1997	Substantially Equivalent	STRYKER CORP.
K945117	DELTA	Feb 28, 1997	Substantially Equivalent	PELTON & CRANE CO.
K953938	STERILEMAX	Jan 30, 1997	Substantially Equivalent	BARNSTEAD/THERMOLYNE CORP.
K962179	STAT IM 5000 CASSETTE AUTOCLAVE	Jan 13, 1997	Substantially Equivalent	SCICAN
K944036	STERIMASTER AUTOCLAVE	Oct 02, 1996	Substantially Equivalent	SCICAN
K954736	ACCESS (POWERCLAVE)	Aug 15, 1996	Substantially Equivalent	MDT BIOLOGIC CO.
K961230	EASTERCLAVE	Jun 27, 1996	Substantially Equivalent	EASTER SERVICES, INC.
K951557	EASTERCLAVE	Sep 29, 1995	Substantially Equivalent	EASTER SERVICES, INC.
K951273	BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER	Aug 08, 1995	Substantially Equivalent	BUXTON MEDICAL SERVIC CORP.
K942989	OCR II & OCM II	Jul 07, 1995	Substantially Equivalent	CHAMBERMAID PRODUCTS CO.
K950341	BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER	Apr 19, 1995	Substantially Equivalent	BARNARD AND ASSOC.
K936181	MIDMARK M-11 ULTRACLAVE STEAM STERILIZER	Nov 30, 1994	Substantially Equivalent	MIDMARK CORP.
K926185	PRIMUS PSS SERIES STERILIZERS	May 09, 1994	Substantially Equivalent	PRIMUS STERILIZER CO., INC.
K924596	SES-2012 AUTOMATIC STEAM STERILIZER	Apr 15, 1994	Substantially Equivalent	PORTER INSTRUMENT CO., INC.
K924955	MDT/HARVEY MC-8 AND MC-10	Oct 15, 1993	Substantially Equivalent	MDT CORP., INC.
K920478	TUTTNAUER LSI (AUTOMATIC)	Jul 08, 1993	Substantially Equivalent	TUTTNAUER CO. LTD.
K921613	STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510	Jan 29, 1993	Substantially Equivalent	DEPT. OF THE ARMY
K915054	STATIM CASSETT AUTOCLAVE, MODIFICATION	Aug 04, 1992	Substantially Equivalent	SCICAN
K912471	EAGLE 3000 SDS	Jun 26, 1992	Substantially Equivalent	AMSCO CO.
K920293	DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY	Apr 21, 1992	Substantially Equivalent	DAVIS & GECK, INC.
K910777	MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER	Mar 27, 1992	Substantially Equivalent	MDT BIOLOGIC CO.
K911206	MAXIMA-10	Nov 29, 1991	Substantially Equivalent	STIRN INDUSTRIES
K910778	STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)	Oct 28, 1991	Substantially Equivalent	MDT BIOLOGIC CO.
K911322	MODEL #M9 ULTRACLAVE STEAM STERILIZER	Aug 26, 1991	Substantially Equivalent	MIDMARK CORP.
K910789	KAVOKLAVE STEAM AUTOCLAVE	Aug 26, 1991	Substantially Equivalent	KAVO AMERICA
K910241	STATIM CASSETTE AUTOCLAVE	May 03, 1991	Substantially Equivalent	SCICAN
K903614	HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE	Dec 14, 1990	Substantially Equivalent	HARVARD APPARATUS, INC.
K901147	JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT	Nov 30, 1990	Substantially Equivalent	JOSLYN VALVE CORP.
K895275	MAC LAVE STEAM STERILIZER	Nov 23, 1990	Substantially Equivalent	MERCHANTS EXPORT DEVELOPMENT CORP.
K903613	HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)	Nov 07, 1990	Substantially Equivalent	HARVARD APPARATUS, INC.
K903096	RACK-IT (R)	Oct 01, 1990	Substantially Equivalent	VENGO INDUSTRIES, INC.
K900432	MODEL #M8 ELECTRONIC STERILIZER	Jul 27, 1990	Substantially Equivalent	MIDMARK CORP.
K895638	STEAM STERILIZER (AUTOCLAVE), DENTAL	Feb 22, 1990	Substantially Equivalent	PORTER INSTRUMENT CO., INC.
K895848	PRESSURE STEAM STERILIZERS	Dec 11, 1989	Substantially Equivalent	SCIENTIFIC DEVICE LABORATORY, INC.
K893886	MITEK STERILIZATION TRAY	Aug 21, 1989	Substantially Equivalent	MITEK SURGICAL PRODUCTS, INC.
K890359	RESUBMITTED STC SERIES 8600 AUTOCLAVE	Aug 07, 1989	Substantially Equivalent	STERILIZER TECHNOLOGIES CORP.
K885140	MULTI-PURPOSE CONTROL SYSTEM	Mar 29, 1989	Substantially Equivalent	COLLIERS STERILIZER SALES & SERVICE CO., INC.
K882713	REBUILDING STERILIZERS	Aug 12, 1988	Substantially Equivalent	MDT CORP., INC.
K882465	MODEL 172-P AND 172-N ROTARY SPRAY ARM	Jun 24, 1988	Substantially Equivalent	BOLING PRECISION COMPONENTS CO.
K874644	STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON	Jan 27, 1988	Substantially Equivalent	PHARMETICS, INC.
K870975	MODIFIED CASTLE POWERCLAVE	Apr 17, 1987	Substantially Equivalent	CASTLE CO.
K862495	STARCRAFT ELITE AUTOCLAVE	Oct 22, 1986	Substantially Equivalent	STARCRAFT MEDICAL CORP.
K852114	ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000	Sep 27, 1985	Substantially Equivalent	ARS ENTERPRISES, INC.
K852113	ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81	Sep 27, 1985	Substantially Equivalent	ARS ENTERPRISES, INC.
K844649	ELECTRICALLY HEATED STERILIZER STEAM STERILIZER	Aug 05, 1985	Substantially Equivalent	TAKIZAWA MEDICAL INSTRUMENTS MANUFACTURER
K850264	TUTTNAUER PRE-VACUUM AUTOCLAVE	Jun 04, 1985	Substantially Equivalent	TUTTNAUER CO. LTD.
K842631	STERELIS SEALING EQUIPMENT	Jul 26, 1984	Substantially Equivalent	STERELIS CORP.
K831356	STEAM STERILIZER	Jul 18, 1984	Substantially Equivalent	ARS ENTERPRISES, INC.
K834152	ETHYLENE OXIDE DETECTOR GLD-1-07	Mar 19, 1984	Substantially Equivalent	CALNOR OF EL PASEO, INC.
K833837	AMERICAN GOLD SERIES AUTOCLAVE	Jan 11, 1984	Substantially Equivalent	TUTTNAUER CO. LTD.
K830931	PORTABLE AUTOCLAVES	Jul 27, 1983	Substantially Equivalent	ARNOLD & SONS
K823457	NON-PRESSURE AUTOCLAVE FOR STERILIZATION	Feb 23, 1983	Substantially Equivalent	INTERDENT, INC.
K821591	STEAM STERILIZATION EQUIPMENT	Jun 22, 1982	Substantially Equivalent	GETINGE INTERNATIONAL, INC.
K801309	RITTER STERILIZER	Jun 20, 1980	Substantially Equivalent	SYBRON CORP.
K800080	STERILIZING CASE CAT. NO. 65199	Jan 28, 1980	Substantially Equivalent	EDWARD WECK, INC.
K792558	CONTAINER SYSTEM	Dec 27, 1979	Substantially Equivalent	AESCULAP INSTRUMENTS CORP.
K781684	STERILIZER, EAGLE 2000	Oct 24, 1978	Substantially Equivalent	AMERICAN STERILIZER CO.
K771229	STERILIZERS, 3100 SERIES TRIM LINE	Aug 02, 1977	Substantially Equivalent	CASTLE CO.
K770682	STERILIZER, SERIES 3000, MODIFICATION TO	May 20, 1977	Substantially Equivalent	CASTLE CO.
K770536	STEAM STERILIZER, 3000	Apr 29, 1977	Substantially Equivalent	CASTLE CO.
K770372	STERILIZER, STEAM, CASTLE 3000	Apr 05, 1977	Substantially Equivalent	CASTLE CO.
K761032	CRADLING SYSTEM	Jan 26, 1977	Substantially Equivalent	MEDIN CORP.

FEI Numbers

This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.

1000119270: 5 registrations

1000273801: 11 registrations

1017522: 4 registrations

1036362: 17 registrations

1219189: 1 registration

1220246: 388 registrations

1523530: 22 registrations

1825014: 34 registrations

1841: 14 registrations

1926681: 166 registrations

2126663: 1 registration

2435367: 10 registrations

2518157: 23 registrations

2916714: 496 registrations

3001061128: 12 registrations

3002579136: 169 registrations

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