510(k) K250168
K250168 is an FDA 510(k) premarket notification submitted by Lucas Lifecare for the device "Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on December 30, 2025. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Lucas Lifecare has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2025
- Date Received
- January 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type