FLE — Sterilizer, Steam Class II
FDA Device Classification
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 |
|---|
| 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 |
| K220736 | consolidated machine | Consolidated HC Steam Sterilizer | August 1, 2022 |