K250168 is an FDA 510(k) clearance for the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Lucas Lifecare (Janesville, US). The FDA issued a Cleared decision on December 30, 2025, 343 days after receiving the submission on January 21, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K250168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | December 30, 2025 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |