K250168
- 510(k) number
- K250168
- Device name
- Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
- Applicant
- Lucas Lifecare WI · US
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2025-12-30
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250168.pdf
Official FDA record: K250168
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.