Clearance Summary
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer received FDA 510(k) clearance under submission number K250168, sponsored by Lucas Lifecare. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-12-30.
- Submission: K250168
- Applicant / Sponsor: Lucas Lifecare
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6880
- Decision date: 2025-12-30
Classification & Regulation
This clearance is catalogued under FDA product code FLE and 21 CFR 880.6880, within the General Hospital review panel as a Class II device.