FLE
- Product code
- FLE
- Device name
- Sterilizer, Steam
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6880
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 185 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261055 | 2026-06-24 | STERIS Corporation | AMSCO 700 Steam Sterilizer | |
| K260254 | 2026-02-26 | Enbio Group AG | Enbio PRO | |
| K252307 | 2026-01-22 | Maquet GmbH (A Getinge Group Company) | Getinge GSS67N Series Steam Sterilizer | |
| K250168 | 2025-12-30 | Lucas Lifecare | Life Ultra 25L Tabletop Mono Chamber Steam Sterilize… | |
| K250164 | 2025-08-14 | Guangzhou Ajax Medical Equipment Co., … | Cassette Autoclave (ACA5) | |
| K243994 | 2025-06-06 | Ningbo Ican Machines Co., Ltd. | Steam Sterilizer (2545D) | FDA |
| K243801 | 2025-03-07 | Fort Defiance Industries, LLC | FRONT-LINE Field Sterilizer (FL135) | |
| K233026 | 2024-04-04 | Midmark Corporation | Midmark Smart M9® Sterilizer, Midmark Smart M11® Ste… | |
| K233504 | 2024-02-08 | W&H Sterilization S.R.L. | Lexa MINI (RIS-303, RIS-305) | — |
| K233132 | 2023-12-19 | Primus Sterilizer Company, LLC | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11… | |
| K232658 | 2023-11-27 | Tuttnauer U.S.A Co, Ltd. | T-Top 10 & T-Top T-Top 11 | |
| K232485 | 2023-09-13 | Steris | AMSCO 600 Steam Sterilizer | FDA |
Official FDA classification page: FLE
Classification and pathway per current FDA publications. Data from openFDA (CC0).