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 |
| 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 |
| K964332 | AMSCO INTL., INC. | EAGLE CENTURY STEAM STERILIZER | 06/01/1998 |
| K170304 | Astell Scientific Limited | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers | 03/02/2018 |
| 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 |
| K191896 | Belimed AG | Belimed Steam Sterilizer MST-H TOP 5000 | 10/31/2019 |
| 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 |
| 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 |
| K220736 | Consolidated Machine Corp. | Consolidated HC Steam Sterilizer | 08/01/2022 |
| K041833 | CONSOLIDATED MACHINE CORP. | CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER | 12/10/2004 |
| K052532 | DENTAL X SRL | IMAX 9.5 STERILIZERS | 09/05/2006 |
| K024133 | DENTSPLY INTL. | CLS-2000 UNIT | 10/01/2003 |
| K961230 | EASTER SERVICES, INC. | EASTERCLAVE | 06/27/1996 |
| K210279 | Enbio Group AG | Enbio S | 10/29/2021 |
| K213991 | Enbio Group AG | Enbio S | 02/22/2022 |
| K213457 | Fort Defiance Industries LLC | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 | 03/02/2022 |
| K141009 | Fort Defiance Industries, Inc. | FORT DEFIANCE AUTOMATED STEAM STERILIZER | 12/16/2014 |
| 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 |
| K050263 | M.O.C.O.M. SRL | MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU | 11/21/2006 |
| K201927 | Maquet GmbH | Getinge GSS610N Series Steam Sterilizer | 03/01/2021 |
| K172159 | Maquet GmbH | Getinge GSS67N Series Steam Sterilizer | 01/30/2018 |
| K214120 | Maquet GmbH | GSS610N21 Series Steam Sterilizer | 05/18/2022 |
| K954736 | MDT BIOLOGIC CO. | ACCESS (POWERCLAVE) | 08/15/1996 |
| K063681 | MEDILINE ITALIA S.R.L. | TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE | 06/29/2007 |
| 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 |
| 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 |
| K945117 | PELTON & CRANE CO. | DELTA | 02/28/1997 |
| K962903 | PRESTIGE MEDICAL CORP. | PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE | 03/03/1998 |
| K991575 | PRIMUS STERILIZER CO., INC. | PRIMUS STEAM STERILIZERS | 12/03/1999 |
| K221474 | PRIMUS Sterilizer Company, LLC | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | 02/10/2023 |
| 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 |
| K944036 | SCICAN | STERIMASTER AUTOCLAVE | 10/02/1996 |
| K090265 | SCICAN LTD. | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V | 05/15/2009 |
| K210326 | SciCan Ltd. | Bravo G4 Chamber Autoclave | 07/01/2021 |
| K190062 | SciCan Ltd. | STATCLAVE G4 Chamber Autoclave | 07/26/2019 |
| K192910 | SciCan Ltd. | STATClave G4 Chamber Autoclave | 06/19/2020 |
| K112872 | SCICAN LTD. | STATIM 2000 G4 CASSETTE | 07/10/2012 |
| K214057 | SciCan Ltd. | STATIM 6000B Vacuum Autoclave | 03/31/2022 |
| K072466 | SCICAN LTD. | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 | 12/19/2007 |
| K220102 | Shinva Medical Instrument Co., Ltd. | MOST-T Autoclave | 10/12/2022 |
| K213545 | Steelco S.P.A. | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | 02/02/2023 |
| K232485 | Steris | AMSCO 600 Steam Sterilizer | 09/13/2023 |
| K212424 | STERIS Corporation | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | 10/28/2021 |
| K211500 | Steris Corporation | AMSCO 600 Medium Steam Sterilizer | 08/25/2021 |
| K183410 | STERIS Corporation | AMSCO 600 Steam Sterilizer | 03/27/2019 |
| 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 |
| K203061 | STERIS Corporation | 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 | 11/06/2020 |
| 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 |
| K962755 | STRYKER CORP. | STRYKER ENCORE STERILIZER | 03/04/1997 |
| K231489 | Sturdy Industrial Co., Ltd | Sturdy Autoclave Super Microm | 06/21/2023 |
| K181993 | Sturdy Industrial Co., Ltd | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) | 11/01/2019 |
| 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 |
| 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 |
| K213080 | Tuttnauer Ltd. | T-Edge 10, T-Edge 11 | 01/04/2022 |
| K221227 | Tuttnauer Ltd. | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | 09/20/2022 |
| K181456 | Tuttnauer Ltd. | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | 07/08/2019 |
| K222608 | Tuttnauer LTD. | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | 12/16/2022 |
| 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 |
| K223858 | W&H Sterilization S.r.l. | Lexa MINI (RIS-303, RIS-305) | 05/05/2023 |
| K213758 | W&H Sterilization s.r.l. | Lexa PLUS RIS-311 | 08/19/2022 |
| K172825 | W&H Sterilization s.r.l. | MN-111 | 05/30/2018 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
