FDA Product Code
FDA Product Code FLE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6880
510(k) Clearances — 185 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | 2026-06-24 | Traditional | PDF ↗ |
| K260254 | Enbio PRO | Enbio Group AG | 2026-02-26 | Traditional | PDF ↗ |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | 2026-01-22 | Traditional | PDF ↗ |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025-12-30 | Traditional | PDF ↗ |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 | Traditional | PDF ↗ |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | 2025-03-07 | Special | PDF ↗ |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | 2024-04-04 | Traditional | PDF ↗ |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2024-02-08 | Traditional | PDF ↗ |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023-12-19 | Abbreviated | PDF ↗ |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 | Traditional | PDF ↗ |
| K232485 | AMSCO 600 Steam Sterilizer | Steris | 2023-09-13 | Special | PDF ↗ |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | 2023-06-21 | Special | PDF ↗ |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2023-05-05 | Traditional | PDF ↗ |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023-02-10 | Abbreviated | PDF ↗ |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | 2023-02-02 | Abbreviated | PDF ↗ |
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Tuttnauer , Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K220102 | MOST-T Autoclave | Shinva Medical Instrument Co., Ltd. | 2022-10-12 | Traditional | PDF ↗ |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Tuttnauer , Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | 2022-08-19 | Traditional | PDF ↗ |
| K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | 2022-08-01 | Abbreviated | PDF ↗ |
| K214120 | GSS610N21 Series Steam Sterilizer | Maquet GmbH | 2022-05-18 | Traditional | PDF ↗ |
| K214057 | STATIM 6000B Vacuum Autoclave | Scican , Ltd. | 2022-03-31 | Abbreviated | PDF ↗ |
| K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 | Fort Defiance Industries, LLC | 2022-03-02 | Abbreviated | PDF ↗ |
| K213991 | Enbio S | Enbio Group AG | 2022-02-22 | Special | PDF ↗ |
| K213080 | T-Edge 10, T-Edge 11 | Tuttnauer , Ltd. | 2022-01-04 | Traditional | PDF ↗ |
| K210279 | Enbio S | Enbio Group AG | 2021-10-29 | Traditional | PDF ↗ |
| K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | STERIS Corporation | 2021-10-28 | Special | PDF ↗ |
| K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | 2021-08-25 | Traditional | PDF ↗ |
| K210326 | Bravo G4 Chamber Autoclave | Scican , Ltd. | 2021-07-01 | Abbreviated | PDF ↗ |
| K201927 | Getinge GSS610N Series Steam Sterilizer | Maquet GmbH | 2021-03-01 | Traditional | PDF ↗ |
| 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) | STERIS Corporation | 2020-11-06 | Special | PDF ↗ |
| K192910 | STATClave G4 Chamber Autoclave | Scican , Ltd. | 2020-06-19 | Abbreviated | PDF ↗ |
| K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) | Sturdy Industrial Co., Ltd. | 2019-11-01 | Traditional | PDF ↗ |
| K191896 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | 2019-10-31 | Abbreviated | PDF ↗ |
| K190062 | STATCLAVE G4 Chamber Autoclave | Scican , Ltd. | 2019-07-26 | Abbreviated | PDF ↗ |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | Tuttnauer , Ltd. | 2019-07-08 | Traditional | PDF ↗ |
| K183410 | AMSCO 600 Steam Sterilizer | STERIS Corporation | 2019-03-27 | Traditional | PDF ↗ |
| K180272 | Saniclave 250 | Revolutionary Science | 2018-07-26 | Traditional | PDF ↗ |
| K172825 | MN-111 | W&H Sterilization S.R.L. | 2018-05-30 | Traditional | PDF ↗ |
| K173481 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018-03-09 | Traditional | PDF ↗ |
| K170304 | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers | Astell Scientific Limited | 2018-03-02 | Traditional | PDF ↗ |
| K173493 | Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 | STERIS Corporation | 2018-02-23 | Traditional | PDF ↗ |
| K173485 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018-02-22 | Traditional | PDF ↗ |
| K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) | STERIS Corporation | 2018-02-22 | Traditional | PDF ↗ |
| K172159 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH | 2018-01-30 | Traditional | PDF ↗ |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer | Midmark Corporation | 2017-08-31 | Traditional | PDF ↗ |
| K170228 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | 2017-05-12 | Abbreviated | PDF ↗ |
| K161848 | Family of Steam sterilizers B17 B22 Series | Cefla S.C. | 2017-02-23 | Traditional | PDF ↗ |
| K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016-03-04 | Traditional | PDF ↗ |
| K141879 | BELIMED STEAM STERILIZER MST-H | Sauter AG | 2015-06-17 | Abbreviated | PDF ↗ |
| K140736 | STERISAFE HP TABLE-TOP STEAM STERILIZER | Milton E Pedrazzi D.D.S., Inc. | 2015-01-20 | Traditional | PDF ↗ |
| K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015-01-15 | Traditional | PDF ↗ |
| K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER | Fort Defiance Industries, Inc. | 2014-12-16 | Traditional | PDF ↗ |
| K132439 | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER | Sakura Seiki Co., Ltd. | 2014-01-06 | Traditional | PDF ↗ |
| K130172 | BELIMED STEAM STERILIZER MST-V | Belimed, Inc. | 2013-09-23 | Abbreviated | PDF ↗ |
| K122978 | SANICLAVE 102, MODEL RS-SC-102 | Alternative Pioneering Research and Development | 2013-05-23 | Traditional | PDF ↗ |
| K122625 | GETINGE 800HC- SERIES STEAM STERILIZER | Getinge Sourcing, LLC | 2013-05-22 | Traditional | PDF ↗ |
| K122774 | SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG | Sakura Seiki Co., Ltd. | 2013-05-09 | Traditional | PDF ↗ |
| K122071 | GETINGE 400HC-E / SERIES STEAM STERILIZER | Getinge Sourcing, LLC | 2013-03-12 | Traditional | PDF ↗ |
| K112872 | STATIM 2000 G4 CASSETTE | Scican , Ltd. | 2012-07-10 | Special | PDF ↗ |
| K120441 | GETINGE 700HC-E SERIES STEAM STERILIZER | Getinge Sourcing, LLC | 2012-05-31 | Traditional | PDF ↗ |
| K120149 | SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA | Sakura Seiki Co., Ltd. | 2012-05-08 | Traditional | PDF ↗ |
| K112403 | AMSCO CHIMERON MEDIUM STEAM STERLILZER | STERIS Corporation | 2012-05-08 | Abbreviated | PDF ↗ |
| K112811 | SANICLAVE 200 | Alternative Pioneering Research and Development | 2012-01-11 | Traditional | PDF ↗ |
| K112055 | AMSCO CHIMERON MEDIUM STEAM STERILIZER | STERIS Corporation | 2011-12-16 | Traditional | PDF ↗ |
| K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | Tuttnauer Co. , Ltd. | 2011-12-08 | Traditional | PDF ↗ |
| K111223 | AMSCO CHIMERON SMALL STEAM STERILIZER | STERIS Corporation | 2011-09-20 | Abbreviated | PDF ↗ |
| K103504 | GETINGE 400HC/500HC SERIES STEAM STERILIZER | Getinge Sourcing, LLC | 2011-03-16 | Traditional | PDF ↗ |
| K103841 | BELIMED STEAM STERILIZER MST-V | Sauter AG | 2011-03-15 | Abbreviated | PDF ↗ |
| K100622 | BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 | Belimed Sauter AG | 2010-08-27 | Abbreviated | PDF ↗ |
| K093333 | PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 | Primus Sterilizer Company, LLC | 2010-04-02 | Abbreviated | PDF ↗ |
| K092490 | AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 | STERIS Corporation | 2009-11-04 | Abbreviated | PDF ↗ |
| K090339 | BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 | Belimed Sauter AG | 2009-09-23 | Traditional | PDF ↗ |
| K091731 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER | STERIS Corporation | 2009-09-17 | Abbreviated | PDF ↗ |
| K090783 | TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE | Tuttnauer U.S.A Co, Ltd. | 2009-08-20 | Traditional | PDF ↗ |
| K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER | Midmark Corp. | 2009-07-07 | Traditional | PDF ↗ |
| K091136 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 | STERIS Corporation | 2009-06-29 | Abbreviated | PDF ↗ |
| K082817 | PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M | Primus Sterilizer Company, LLC | 2009-05-21 | Traditional | PDF ↗ |
| K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V | Scican , Ltd. | 2009-05-15 | Abbreviated | PDF ↗ |
| K082435 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER | STERIS Corporation | 2008-12-30 | Abbreviated | PDF ↗ |
| K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 | Scican , Ltd. | 2007-12-19 | Traditional | PDF ↗ |
| K072087 | BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 | Belimed Sauter AG | 2007-10-05 | Traditional | PDF ↗ |
| K063681 | TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE | Mediline Italia S.R.L. | 2007-06-29 | Traditional | PDF ↗ |
| K070657 | GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER | Getinge Sourcing, LLC | 2007-04-05 | Special | PDF ↗ |
| K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA | Tuttnauer Co. , Ltd. | 2007-02-02 | Traditional | PDF ↗ |
| K050263 | MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU | M.O. Com S.R.L. | 2006-11-21 | Abbreviated | PDF ↗ |
| K052532 | IMAX 9.5 STERILIZERS | Dental X Srl | 2006-09-05 | Traditional | PDF ↗ |
| K060337 | BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 | Sauter AG | 2006-03-08 | Special | PDF ↗ |
| K041833 | CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER | Consolidated Machine Corp. | 2004-12-10 | Abbreviated | PDF ↗ |
| K032192 | PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V | Tuttnauer U.S.A Co, Ltd. | 2004-08-12 | Abbreviated | PDF ↗ |
| K033538 | BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 | Sauter AG | 2004-02-02 | Special | PDF ↗ |
| K024133 | CLS-2000 UNIT | Dentsply Intl. | 2003-10-01 | Traditional | PDF ↗ |
| K031259 | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER | Getinge USA, Inc. | 2003-05-12 | Special | PDF ↗ |
| K030789 | AMSCO CENTURY STEAM STERILIZER | STERIS Corporation | 2003-03-26 | Special | PDF ↗ |
| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | Midmark Corp. | 2003-03-03 | Traditional | PDF ↗ |
| K022816 | W & H LISA STEAM STERILIZER | A-Dec, Inc. | 2003-02-07 | Abbreviated | PDF ↗ |
| K021064 | QUANTIM 16 AUTOCLAVE | Scican | 2002-08-08 | Traditional | PDF ↗ |
| K021504 | TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 | Tuttnauer U.S.A Co, Ltd. | 2002-07-25 | Abbreviated | PDF ↗ |
| K021223 | BELIMED STEAM STERILIZER, MODEL TOP 5000 | Sauter AG | 2002-06-26 | Traditional | PDF ↗ |
Product code FLE · Class II · General Hospital. Data: openFDA.