Panels › General Hospital › Product code FLE · Class 2
Sterilizer, Steam
Regulation 880.6880
4510(k)s in 12 months (185 all time)
1recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in FLE
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 23 | 10 |
| Tuttnauer , Ltd. | 18 | 0 |
| Scican | 13 | 2 |
| Midmark Corp. | 9 | 1 |
| Fort Defiance Industries, Inc. | 3 | 3 |
| Getinge/Castle, Inc. | 6 | 0 |
| Primus Sterilizer Co., Inc. | 6 | 0 |
| Castle Co. | 5 | 0 |
| Getinge Sourcing, LLC | 5 | 0 |
| Sauter AG | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2026 | K261055 | AMSCO 700 Steam Sterilizer STERIS Corporation | FLE |
| Feb 26, 2026 | K260254 | Enbio PRO Enbio Group AG, CH | FLE |
| Jan 22, 2026 | K252307 | Getinge GSS67N Series Steam Sterilizer Maquet GmbH (A Getinge Group Company), DE | FLE |
| Dec 30, 2025 | K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer Lucas Lifecare | FLE |
| Aug 14, 2025 | K250164 | Cassette Autoclave (ACA5) Guangzhou Ajax Medical Equipment Co., Ltd., CN | FLE |
| Jun 6, 2025 | K243994 | Steam Sterilizer (2545D) Ningbo Ican Machines Co., Ltd., CN | FLE |
| Mar 7, 2025 | K243801 | FRONT-LINE Field Sterilizer (FL135) Fort Defiance Industries, LLC | FLE |
| Apr 4, 2024 | K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer Midmark Corporation | FLE |
| Feb 8, 2024 | K233504 | Lexa MINI (RIS-303, RIS-305) W&H Sterilization S.R.L., IT | FLE |
| Dec 19, 2023 | K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) Primus Sterilizer Company, LLC | FLE |
| Nov 27, 2023 | K232658 | T-Top 10 & T-Top T-Top 11 Tuttnauer U.S.A Co, Ltd. | FLE |
| Sep 13, 2023 | K232485 | AMSCO 600 Steam Sterilizer Steris | FLE |
| Jun 21, 2023 | K231489 | Sturdy Autoclave Super Microm Sturdy Industrial Co., Ltd., TW | FLE |
| May 5, 2023 | K223858 | Lexa MINI (RIS-303, RIS-305) W&H Sterilization S.R.L., IT | FLE |
| Feb 10, 2023 | K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) Primus Sterilizer Company, LLC | FLE |
| Feb 2, 2023 | K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 Steelco S.P.A., IT | FLE |
| Dec 16, 2022 | K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS Tuttnauer , Ltd., IL | FLE |
| Oct 12, 2022 | K220102 | MOST-T Autoclave Shinva Medical Instrument Co., Ltd., CN | FLE |
| Sep 20, 2022 | K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 Tuttnauer , Ltd., IL | FLE |
| Aug 19, 2022 | K213758 | Lexa PLUS RIS-311 W&H Sterilization S.R.L., IT | FLE |
| Aug 1, 2022 | K220736 | Consolidated HC Steam Sterilizer Consolidated Machine Corp. | FLE |
| May 18, 2022 | K214120 | GSS610N21 Series Steam Sterilizer Maquet GmbH, DE | FLE |
| Mar 31, 2022 | K214057 | STATIM 6000B Vacuum Autoclave Scican , Ltd., CA | FLE |
| Mar 2, 2022 | K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 Fort Defiance Industries, LLC | FLE |
| Feb 22, 2022 | K213991 | Enbio S Enbio Group AG, CH | FLE |
| Jan 4, 2022 | K213080 | T-Edge 10, T-Edge 11 Tuttnauer , Ltd., IL | FLE |
| Oct 29, 2021 | K210279 | Enbio S Enbio Group AG, CH | FLE |
| Oct 28, 2021 | K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers STERIS Corporation | FLE |
| Aug 25, 2021 | K211500 | AMSCO 600 Medium Steam Sterilizer STERIS Corporation | FLE |
| Jul 1, 2021 | K210326 | Bravo G4 Chamber Autoclave Scican , Ltd., CA | FLE |
| Mar 1, 2021 | K201927 | Getinge GSS610N Series Steam Sterilizer Maquet GmbH, DE | FLE |
| Nov 6, 2020 | K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (AL STERIS Corporation | FLE |
| Jun 19, 2020 | K192910 | STATClave G4 Chamber Autoclave Scican , Ltd., CA | FLE |
| Nov 1, 2019 | K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) Sturdy Industrial Co., Ltd., TW | FLE |
| Oct 31, 2019 | K191896 | Belimed Steam Sterilizer MST-H TOP 5000 Belimed AG, CH | FLE |
| Jul 26, 2019 | K190062 | STATCLAVE G4 Chamber Autoclave Scican , Ltd., CA | FLE |
| Jul 8, 2019 | K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves Tuttnauer , Ltd., IL | FLE |
| Mar 27, 2019 | K183410 | AMSCO 600 Steam Sterilizer STERIS Corporation | FLE |
| Jul 26, 2018 | K180272 | Saniclave 250 Revolutionary Science | FLE |
| May 30, 2018 | K172825 | MN-111 W&H Sterilization S.R.L., IT | FLE |
| Mar 9, 2018 | K173481 | Amsco Evolution Medium Steam Sterilizer STERIS Corporation | FLE |
| Mar 2, 2018 | K170304 | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers Astell Scientific Limited, GB | FLE |
| Feb 23, 2018 | K173493 | Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 STERIS Corporation | FLE |
| Feb 22, 2018 | K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) STERIS Corporation | FLE |
| Feb 22, 2018 | K173485 | Amsco Evolution Medium Steam Sterilizer STERIS Corporation | FLE |
| Jan 30, 2018 | K172159 | Getinge GSS67N Series Steam Sterilizer Maquet GmbH, DE | FLE |
| Aug 31, 2017 | K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer Midmark Corporation | FLE |
| May 12, 2017 | K170228 | Belimed Steam Sterilizer MST-H TOP 5000 Belimed AG, CH | FLE |
| Feb 23, 2017 | K161848 | Family of Steam sterilizers B17 B22 Series Cefla S.C., IT | FLE |
| Mar 4, 2016 | K151597 | Family of Steam Sterilizers B 28 series Cefla S.C., IT | FLE |
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