FDA 510(k) Applications for Medical Device Product Code "FLE"
(Sterilizer, Steam)

FDA 510(k) Number Applicant Device Name Decision Date
K022816 A-DEC, INC. W & H LISA STEAM STERILIZER 02/07/2003
K954142 ADVANCED STERILIZATION PRODUCTS STERRADD STERILIZATION SYSTEM 06/06/1997
K792558 AESCULAP INSTRUMENTS CORP. CONTAINER SYSTEM 12/27/1979
K122978 ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT SANICLAVE 102, MODEL RS-SC-102 05/23/2013
K112811 ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT SANICLAVE 200 01/11/2012
K781684 AMERICAN STERILIZER CO. STERILIZER, EAGLE 2000 10/24/1978
K912471 AMSCO CO. EAGLE 3000 SDS 06/26/1992
K964332 AMSCO INTL., INC. EAGLE CENTURY STEAM STERILIZER 06/01/1998
K830931 ARNOLD & SONS PORTABLE AUTOCLAVES 07/27/1983
K852113 ARS ENTERPRISES, INC. ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 09/27/1985
K852114 ARS ENTERPRISES, INC. ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 09/27/1985
K831356 ARS ENTERPRISES, INC. STEAM STERILIZER 07/18/1984
K170304 Astell Scientific Limited Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers 03/02/2018
K950341 BARNARD AND ASSOC. BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER 04/19/1995
K014174 BARNSTEAD/THERMOLYNE CORP. HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 02/22/2002
K953938 BARNSTEAD/THERMOLYNE CORP. STERILEMAX 01/30/1997
K170228 Belimed AG Belimed Steam Sterilizer MST-H TOP 5000 05/12/2017
K072087 BELIMED SAUTER AG BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 10/05/2007
K090339 BELIMED SAUTER AG BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 09/23/2009
K100622 BELIMED SAUTER AG BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 08/27/2010
K130172 BELIMED, INC. BELIMED STEAM STERILIZER MST-V 09/23/2013
K882465 BOLING PRECISION COMPONENTS CO. MODEL 172-P AND 172-N ROTARY SPRAY ARM 06/24/1988
K951273 BUXTON MEDICAL SERVIC CORP. BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER 08/08/1995
K834152 CALNOR OF EL PASEO, INC. ETHYLENE OXIDE DETECTOR GLD-1-07 03/19/1984
K870975 CASTLE CO. MODIFIED "CASTLE POWERCLAVE" 04/17/1987
K770536 CASTLE CO. STEAM STERILIZER, 3000 04/29/1977
K770682 CASTLE CO. STERILIZER, SERIES 3000, MODIFICATION TO 05/20/1977
K770372 CASTLE CO. STERILIZER, STEAM, CASTLE 3000 04/05/1977
K771229 CASTLE CO. STERILIZERS, 3100 SERIES TRIM LINE 08/02/1977
K151597 CEFLA S.C. Family of Steam Sterilizers B 28 series 03/04/2016
K161848 CEFLA S.C. Family of Steam sterilizers B17 B22 Series 02/23/2017
K942989 CHAMBERMAID PRODUCTS CO. OCR II & OCM II 07/07/1995
K885140 COLLIERS STERILIZER SALES & SERVICE CO., INC. MULTI-PURPOSE CONTROL SYSTEM 03/29/1989
K041833 CONSOLIDATED MACHINE CORP. CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER 12/10/2004
K920293 DAVIS & GECK, INC. DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY 04/21/1992
K052532 DENTAL X SRL IMAX 9.5 STERILIZERS 09/05/2006
K024133 DENTSPLY INTL. CLS-2000 UNIT 10/01/2003
K921613 DEPT. OF THE ARMY STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 01/29/1993
K951557 EASTER SERVICES, INC. EASTERCLAVE 09/29/1995
K961230 EASTER SERVICES, INC. EASTERCLAVE 06/27/1996
K800080 EDWARD WECK, INC. STERILIZING CASE CAT. NO. 65199 01/28/1980
K141009 Fort Defiance Industries, Inc. FORT DEFIANCE AUTOMATED STEAM STERILIZER 12/16/2014
K821591 GETINGE INTERNATIONAL, INC. STEAM STERILIZATION EQUIPMENT 06/22/1982
K122071 GETINGE SOURCING LLC GETINGE 400HC-E / SERIES STEAM STERILIZER 03/12/2013
K070657 GETINGE SOURCING LLC GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER 04/05/2007
K120441 GETINGE SOURCING LLC GETINGE 700HC-E SERIES STEAM STERILIZER 05/31/2012
K122625 GETINGE SOURCING LLC GETINGE 800HC- SERIES STEAM STERILIZER 05/22/2013
K103504 GETINGE SOURCING, LLC GETINGE 400HC/500HC SERIES STEAM STERILIZER 03/16/2011
K031259 GETINGE USA, INC MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER 05/12/2003
K012573 GETINGE/CASTLE, INC. CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC 09/05/2001
K003441 GETINGE/CASTLE, INC. CASTLE MODEL 233HC STEAM STERILIZER 01/02/2001
K970907 GETINGE/CASTLE, INC. CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) 11/12/1997
K994314 GETINGE/CASTLE, INC. CASTLE SERIES 100HC STEAM STERILIZERS 02/16/2000
K973225 GETINGE/CASTLE, INC. CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) 02/10/1998
K020590 GETINGE/CASTLE, INC. MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER 03/20/2002
K903613 HARVARD APPARATUS, INC. HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) 11/07/1990
K903614 HARVARD APPARATUS, INC. HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE 12/14/1990
K823457 INTERDENT, INC. NON-PRESSURE AUTOCLAVE FOR STERILIZATION 02/23/1983
K901147 JOSLYN VALVE CORP. JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT 11/30/1990
K910789 KAVO AMERICA KAVOKLAVE STEAM AUTOCLAVE 08/26/1991
K050263 M.O.C.O.M. SRL MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU 11/21/2006
K172159 Maquet GmbH Getinge GSS67N Series Steam Sterilizer 01/30/2018
K954736 MDT BIOLOGIC CO. ACCESS (POWERCLAVE) 08/15/1996
K910777 MDT BIOLOGIC CO. MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER 03/27/1992
K910778 MDT BIOLOGIC CO. STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) 10/28/1991
K924955 MDT CORP., INC. MDT/HARVEY MC-8 AND MC-10 10/15/1993
K882713 MDT CORP., INC. REBUILDING STERILIZERS 08/12/1988
K063681 MEDILINE ITALIA S.R.L. TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE 06/29/2007
K761032 MEDIN CORP. CRADLING SYSTEM 01/26/1977
K895275 MERCHANTS EXPORT DEVELOPMENT CORP. MAC LAVE STEAM STERILIZER 11/23/1990
K936181 MIDMARK CORP. MIDMARK M-11 ULTRACLAVE STEAM STERILIZER 11/30/1994
K090670 MIDMARK CORP. MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER 07/07/2009
K992744 MIDMARK CORP. MIDMARK M4*9 EASYCLAVE STEAM STERILIZER 01/10/2000
K023348 MIDMARK CORP. MIDMARK M9 ULTRACLAVE STEAM STERILIZER 03/03/2003
K900432 MIDMARK CORP. MODEL #M8 ELECTRONIC STERILIZER 07/27/1990
K911322 MIDMARK CORP. MODEL #M9 ULTRACLAVE STEAM STERILIZER 08/26/1991
K990189 MIDMARK CORP. MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER 04/19/1999
K163337 Midmark Corporation Midmark and Ritter M9 and M11 UltraClave« Automatic Sterilizers and Ritter M9D AutoClave« Automatic Sterilizer 08/31/2017
K140736 MILTON E PEDRAZZI D.D.S., INC. STERISAFE HP TABLE-TOP STEAM STERILIZER 01/20/2015
K893886 MITEK SURGICAL PRODUCTS, INC. MITEK STERILIZATION TRAY 08/21/1989
K945117 PELTON & CRANE CO. DELTA 02/28/1997
K874644 PHARMETICS, INC. STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON 01/27/1988
K924596 PORTER INSTRUMENT CO., INC. SES-2012 AUTOMATIC STEAM STERILIZER 04/15/1994
K895638 PORTER INSTRUMENT CO., INC. STEAM STERILIZER (AUTOCLAVE), DENTAL 02/22/1990
K962903 PRESTIGE MEDICAL CORP. PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE 03/03/1998
K926185 PRIMUS STERILIZER CO., INC. PRIMUS PSS SERIES STERILIZERS 05/09/1994
K991575 PRIMUS STERILIZER CO., INC. PRIMUS STEAM STERILIZERS 12/03/1999
K093333 PRIMUS STERILIZER COMPANY, LLC. PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 04/02/2010
K082817 PRIMUS STERILIZER COMPANY, LLC. PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M 05/21/2009
K180272 REVOLUTIONARY SCIENCE Saniclave 250 07/26/2018
K122774 SAKURA SEIKI CO., LTD. SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG 05/09/2013
K132439 SAKURA SEIKI CO., LTD. SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER 01/06/2014
K120149 SAKURA SEIKI CO., LTD. SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA 05/08/2012
K141879 SAUTER AG BELIMED STEAM STERILIZER MST-H 06/17/2015
K103841 SAUTER AG BELIMED STEAM STERILIZER MST-V 03/15/2011
K060337 SAUTER AG BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 03/08/2006
K033538 SAUTER AG BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 02/02/2004
K021223 SAUTER AG BELIMED STEAM STERILIZER, MODEL TOP 5000 06/26/2002
K021064 SCICAN QUANTIM 16 AUTOCLAVE 08/08/2002
K962179 SCICAN STAT IM 5000 CASSETTE AUTOCLAVE 01/13/1997
K983679 SCICAN STATIM 5000 CASSETTE AUTOCLAVE 01/04/1999
K915054 SCICAN STATIM CASSETT AUTOCLAVE, MODIFICATION 08/04/1992
K910241 SCICAN STATIM CASSETTE AUTOCLAVE 05/03/1991
K944036 SCICAN STERIMASTER AUTOCLAVE 10/02/1996
K090265 SCICAN LTD. BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V 05/15/2009
K112872 SCICAN LTD. STATIM 2000 G4 CASSETTE 07/10/2012
K072466 SCICAN LTD. STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 12/19/2007
K895848 SCIENTIFIC DEVICE LABORATORY, INC. PRESSURE STEAM STERILIZERS 12/11/1989
K862495 STARCRAFT MEDICAL CORP. STARCRAFT "ELITE" AUTOCLAVE 10/22/1986
K842631 STERELIS CORP. STERELIS SEALING EQUIPMENT 07/26/1984
K890359 STERILIZER TECHNOLOGIES CORP. RESUBMITTED STC SERIES 8600 AUTOCLAVE 08/07/1989
K020747 STERIS Corporation AMSCO CENTURY MEDIUM STERILIZER 26 X 26 05/17/2002
K010865 STERIS Corporation AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY 05/31/2001
K030789 STERIS Corporation AMSCO CENTURY STEAM STERILIZER 03/26/2003
K112055 STERIS Corporation AMSCO CHIMERON MEDIUM STEAM STERILIZER 12/16/2011
K112403 STERIS Corporation AMSCO CHIMERON MEDIUM STEAM STERLILZER 05/08/2012
K111223 STERIS Corporation AMSCO CHIMERON SMALL STEAM STERILIZER 09/20/2011
K173493 STERIS Corporation Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 02/23/2018
K173481 STERIS Corporation Amsco Evolution Medium Steam Sterilizer 03/09/2018
K173485 STERIS Corporation Amsco Evolution Medium Steam Sterilizer 02/22/2018
K082435 STERIS Corporation AMSCO EVOLUTION MEDIUM STEAM STERILIZER 12/30/2008
K091731 STERIS Corporation AMSCO EVOLUTION MEDIUM STEAM STERILIZER 09/17/2009
K173490 STERIS Corporation Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) 02/22/2018
K091136 STERIS Corporation AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 06/29/2009
K092490 STERIS Corporation AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 11/04/2009
K000077 STERIS Corporation STERIS AMSCO MILLENNIUM STEAM STERILIZER 03/17/2000
K982332 STERIS Corporation STERIS TEN SIXTEEN STEAM STERILIZER 01/20/1999
K980014 STERIS Corporation THE SYSTEM 2S STEAM STERILIZER 05/15/1998
K911206 STIRN INDUSTRIES MAXIMA-10 11/29/1991
K962755 STRYKER CORP. STRYKER ENCORE STERILIZER 03/04/1997
K801309 SYBRON CORP. RITTER STERILIZER 06/20/1980
K844649 TAKIZAWA MEDICAL INSTRUMENTS MANUFACTURER ELECTRICALLY HEATED STERILIZER STEAM STERILIZER 08/05/1985
K833837 TUTTNAUER CO. LTD. AMERICAN GOLD SERIES AUTOCLAVE 01/11/1984
K003470 TUTTNAUER CO. LTD. EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 02/20/2001
K111736 TUTTNAUER CO. LTD. TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES 12/08/2011
K920478 TUTTNAUER CO. LTD. TUTTNAUER LSI (AUTOMATIC) 07/08/1993
K850264 TUTTNAUER CO. LTD. TUTTNAUER PRE-VACUUM AUTOCLAVE 06/04/1985
K063711 TUTTNAUER CO. LTD. TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA 02/02/2007
K032192 TUTTNAUER USA CO. LTD. PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V 08/12/2004
K143311 TUTTNAUER USA CO. LTD. Pre-vacuum Tabletop Autoclave 01/15/2015
K021504 TUTTNAUER USA CO. LTD. TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 07/25/2002
K090783 TUTTNAUER USA CO. LTD. TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE 08/20/2009
K993856 TUTTNAUER USA CO. LTD. TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP 02/09/2001
K962282 TUTTNAUER USA CO. LTD. TUTTNAUER PREVACUUM TABLE AUTOCLAVE 11/12/1997
K973550 TUTTNAUER USA CO. LTD. TUTTNAUER TABLE-TOP AUTOCLAVE 10/29/1997
K903096 VENGO INDUSTRIES, INC. RACK-IT (R) 10/01/1990
K172825 W&H Sterilization s.r.l. MN-111 05/30/2018


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