FLE — Sterilizer, Steam Class II
FDA product code FLE covers "Sterilizer, Steam", a Class II medical device regulated under 21 CFR 880.6880. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FLE
- Device Class
- Class II
- Regulation Number
- 880.6880
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261055 | steris corporation | AMSCO 700 Steam Sterilizer | June 24, 2026 |
| K260254 | enbio group | Enbio PRO | February 26, 2026 |
| K252307 | maquet gmbh (a getinge group company) | Getinge GSS67N Series Steam Sterilizer | January 22, 2026 |
| K250168 | lucas lifecare | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | December 30, 2025 |
| K250164 | guangzhou ajax medical equipment co | Cassette Autoclave (ACA5) | August 14, 2025 |
| K243994 | ningbo ican machines co | Steam Sterilizer (2545D) | June 6, 2025 |
| K243801 | fort defiance industries | FRONT-LINE Field Sterilizer (FL135) | March 7, 2025 |
| K233026 | midmark corporation | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | April 4, 2024 |
| K233504 | w and h sterilization | Lexa MINI (RIS-303, RIS-305) | February 8, 2024 |
| K233132 | primus sterilizer company | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | December 19, 2023 |
| K232658 | tuttnauer u.s.a co | T-Top 10 & T-Top T-Top 11 | November 27, 2023 |
| K232485 | steris | AMSCO 600 Steam Sterilizer | September 13, 2023 |
| K231489 | sturdy industrial co | Sturdy Autoclave Super Microm | June 21, 2023 |
| K223858 | w and h sterilization | Lexa MINI (RIS-303, RIS-305) | May 5, 2023 |
| K221474 | primus sterilizer company | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | February 10, 2023 |
| K213545 | steelco | Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 | February 2, 2023 |
| K222608 | tuttnauer | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | December 16, 2022 |
| K220102 | shinva medical instrument co | MOST-T Autoclave | October 12, 2022 |
| K221227 | tuttnauer | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | September 20, 2022 |
| K213758 | w and h sterilization | Lexa PLUS RIS-311 | August 19, 2022 |