Product code FLE
- Device name
- Sterilizer, Steam
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6880
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | 2026-06-24 |
| K260254 | Enbio PRO | Enbio Group AG | 2026-02-26 |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | 2026-01-22 |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025-12-30 |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | 2025-03-07 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | 2024-04-04 |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2024-02-08 |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023-12-19 |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 |
| K232485 | AMSCO 600 Steam Sterilizer | Steris | 2023-09-13 |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | 2023-06-21 |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2023-05-05 |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023-02-10 |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | Steelco S.P.A. | 2023-02-02 |
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Tuttnauer , Ltd. | 2022-12-16 |
| K220102 | MOST-T Autoclave | Shinva Medical Instrument Co., Ltd. | 2022-10-12 |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Tuttnauer , Ltd. | 2022-09-20 |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | 2022-08-19 |
| K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | 2022-08-01 |
| K214120 | GSS610N21 Series Steam Sterilizer | Maquet GmbH | 2022-05-18 |
| K214057 | STATIM 6000B Vacuum Autoclave | Scican , Ltd. | 2022-03-31 |
| K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 | Fort Defiance Industries, LLC | 2022-03-02 |
| K213991 | Enbio S | Enbio Group AG | 2022-02-22 |
| K213080 | T-Edge 10, T-Edge 11 | Tuttnauer , Ltd. | 2022-01-04 |
| K210279 | Enbio S | Enbio Group AG | 2021-10-29 |
| K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers | STERIS Corporation | 2021-10-28 |
| K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | 2021-08-25 |
| K210326 | Bravo G4 Chamber Autoclave | Scican , Ltd. | 2021-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00724995150471 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150662 | Eagle | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150655 | Eagle | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150648 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150631 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150624 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150617 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150600 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150594 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150587 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150570 | Amsco | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150563 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150556 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150549 | Atlas | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150488 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150327 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150464 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150457 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150440 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150433 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150426 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150419 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150402 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150396 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150389 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150372 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150365 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150358 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150341 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |
| 00724995150334 | NA | Steris Mexico, S. de R.L. de C.V. | 2016-09-14 |