Atlas FDA

FLE

185 FDA 510(k) clearances · Product code

135 daysmedian time to decision
395 days90th percentile
185clearances measured

FDA profile

Official device name
Sterilizer, Steam
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6880
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 81 · 2022: 70 · 2023: 66 · 2024: 64 · 2025: 71 · 2026: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AMSCO 700 Steam Sterilizer (K261055)STERIS Corporation2026-06-24
Enbio PRO (K260254)Enbio Group AG2026-02-26
Getinge GSS67N Series Steam Sterilizer (K252307)Maquet GmbH (A Getinge Group Company)2026-01-22
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (K250168)Lucas Lifecare2025-12-30
Cassette Autoclave (ACA5) (K250164)Guangzhou Ajax Medical Equipment Co., Ltd.2025-08-14
Steam Sterilizer (2545D) (K243994)Ningbo Ican Machines Co., Ltd.2025-06-06
FRONT-LINE Field Sterilizer (FL135) (K243801)Fort Defiance Industries, LLC2025-03-07
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (K233026)Midmark Corporation2024-04-04
Lexa MINI (RIS-303, RIS-305) (K233504)W&H Sterilization S.R.L.2024-02-08
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (K233132)Primus Sterilizer Company, LLC2023-12-19
T-Top 10 & T-Top T-Top 11 (K232658)Tuttnauer U.S.A Co, Ltd.2023-11-27
AMSCO 600 Steam Sterilizer (K232485)Steris2023-09-13
Sturdy Autoclave Super Microm (K231489)Sturdy Industrial Co., Ltd.2023-06-21
Lexa MINI (RIS-303, RIS-305) (K223858)W&H Sterilization S.R.L.2023-05-05
PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474)Primus Sterilizer Company, LLC2023-02-10
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 (K213545)Steelco S.P.A.2023-02-02
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS (K222608)Tuttnauer , Ltd.2022-12-16
MOST-T Autoclave (K220102)Shinva Medical Instrument Co., Ltd.2022-10-12
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 (K221227)Tuttnauer , Ltd.2022-09-20
Lexa PLUS RIS-311 (K213758)W&H Sterilization S.R.L.2022-08-19
Consolidated HC Steam Sterilizer (K220736)Consolidated Machine Corp.2022-08-01
GSS610N21 Series Steam Sterilizer (K214120)Maquet GmbH2022-05-18
STATIM 6000B Vacuum Autoclave (K214057)Scican , Ltd.2022-03-31
Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 (K213457)Fort Defiance Industries, LLC2022-03-02
Enbio S (K213991)Enbio Group AG2022-02-22
T-Edge 10, T-Edge 11 (K213080)Tuttnauer , Ltd.2022-01-04
Enbio S (K210279)Enbio Group AG2021-10-29
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers (K212424)STERIS Corporation2021-10-28
AMSCO 600 Medium Steam Sterilizer (K211500)STERIS Corporation2021-08-25
Bravo G4 Chamber Autoclave (K210326)Scican , Ltd.2021-07-01
Getinge GSS610N Series Steam Sterilizer (K201927)Maquet GmbH2021-03-01
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) (K203061)STERIS Corporation2020-11-06
STATClave G4 Chamber Autoclave (K192910)Scican , Ltd.2020-06-19
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) (K181993)Sturdy Industrial Co., Ltd.2019-11-01
Belimed Steam Sterilizer MST-H TOP 5000 (K191896)Belimed AG2019-10-31
STATCLAVE G4 Chamber Autoclave (K190062)Scican , Ltd.2019-07-26
Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves (K181456)Tuttnauer , Ltd.2019-07-08
AMSCO 600 Steam Sterilizer (K183410)STERIS Corporation2019-03-27
Saniclave 250 (K180272)Revolutionary Science2018-07-26
MN-111 (K172825)W&H Sterilization S.R.L.2018-05-30
Amsco Evolution Medium Steam Sterilizer (K173481)STERIS Corporation2018-03-09
Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers (K170304)Astell Scientific Limited2018-03-02
Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 (K173493)STERIS Corporation2018-02-23
Amsco Evolution Medium Steam Sterilizer (K173485)STERIS Corporation2018-02-22
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) (K173490)STERIS Corporation2018-02-22
Getinge GSS67N Series Steam Sterilizer (K172159)Maquet GmbH2018-01-30
Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (K163337)Midmark Corporation2017-08-31
Belimed Steam Sterilizer MST-H TOP 5000 (K170228)Belimed AG2017-05-12
Family of Steam sterilizers B17 B22 Series (K161848)Cefla S.C.2017-02-23
Family of Steam Sterilizers B 28 series (K151597)Cefla S.C.2016-03-04
BELIMED STEAM STERILIZER MST-H (K141879)Sauter AG2015-06-17
STERISAFE HP TABLE-TOP STEAM STERILIZER (K140736)Milton E Pedrazzi D.D.S., Inc.2015-01-20
Pre-vacuum Tabletop Autoclave (K143311)Tuttnauer U.S.A Co, Ltd.2015-01-15
FORT DEFIANCE AUTOMATED STEAM STERILIZER (K141009)Fort Defiance Industries, Inc.2014-12-16
SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER (K132439)Sakura Seiki Co., Ltd.2014-01-06
BELIMED STEAM STERILIZER MST-V (K130172)Belimed, Inc.2013-09-23
SANICLAVE 102, MODEL RS-SC-102 (K122978)Alternative Pioneering Research and Development2013-05-23
GETINGE 800HC- SERIES STEAM STERILIZER (K122625)Getinge Sourcing, LLC2013-05-22
SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG (K122774)Sakura Seiki Co., Ltd.2013-05-09
GETINGE 400HC-E / SERIES STEAM STERILIZER (K122071)Getinge Sourcing, LLC2013-03-12
STATIM 2000 G4 CASSETTE (K112872)Scican , Ltd.2012-07-10
GETINGE 700HC-E SERIES STEAM STERILIZER (K120441)Getinge Sourcing, LLC2012-05-31
AMSCO CHIMERON MEDIUM STEAM STERLILZER (K112403)STERIS Corporation2012-05-08
SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA (K120149)Sakura Seiki Co., Ltd.2012-05-08
SANICLAVE 200 (K112811)Alternative Pioneering Research and Development2012-01-11
AMSCO CHIMERON MEDIUM STEAM STERILIZER (K112055)STERIS Corporation2011-12-16
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES (K111736)Tuttnauer Co. , Ltd.2011-12-08
AMSCO CHIMERON SMALL STEAM STERILIZER (K111223)STERIS Corporation2011-09-20
GETINGE 400HC/500HC SERIES STEAM STERILIZER (K103504)Getinge Sourcing, LLC2011-03-16
BELIMED STEAM STERILIZER MST-V (K103841)Sauter AG2011-03-15
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 (K100622)Belimed Sauter AG2010-08-27
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 (K093333)Primus Sterilizer Company, LLC2010-04-02
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 (K092490)STERIS Corporation2009-11-04
BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 (K090339)Belimed Sauter AG2009-09-23
AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K091731)STERIS Corporation2009-09-17
TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE (K090783)Tuttnauer U.S.A Co, Ltd.2009-08-20
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER (K090670)Midmark Corp.2009-07-07
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 (K091136)STERIS Corporation2009-06-29
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M (K082817)Primus Sterilizer Company, LLC2009-05-21
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V (K090265)Scican , Ltd.2009-05-15
AMSCO EVOLUTION MEDIUM STEAM STERILIZER (K082435)STERIS Corporation2008-12-30
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 (K072466)Scican , Ltd.2007-12-19
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 (K072087)Belimed Sauter AG2007-10-05
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE (K063681)Mediline Italia S.R.L.2007-06-29
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER (K070657)Getinge Sourcing, LLC2007-04-05
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA (K063711)Tuttnauer Co. , Ltd.2007-02-02
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU (K050263)M.O. Com S.R.L.2006-11-21
IMAX 9.5 STERILIZERS (K052532)Dental X Srl2006-09-05
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 (K060337)Sauter AG2006-03-08
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER (K041833)Consolidated Machine Corp.2004-12-10
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V (K032192)Tuttnauer U.S.A Co, Ltd.2004-08-12
BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 (K033538)Sauter AG2004-02-02
CLS-2000 UNIT (K024133)Dentsply Intl.2003-10-01
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER (K031259)Getinge USA, Inc.2003-05-12
AMSCO CENTURY STEAM STERILIZER (K030789)STERIS Corporation2003-03-26
MIDMARK M9 ULTRACLAVE STEAM STERILIZER (K023348)Midmark Corp.2003-03-03
W & H LISA STEAM STERILIZER (K022816)A-Dec, Inc.2003-02-07
QUANTIM 16 AUTOCLAVE (K021064)Scican2002-08-08
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 (K021504)Tuttnauer U.S.A Co, Ltd.2002-07-25
BELIMED STEAM STERILIZER, MODEL TOP 5000 (K021223)Sauter AG2002-06-26
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