Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer— 510(k) K250168
Substantially EquivalentLucas Lifecare
FDA 510(k) clearance K250168 for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer, Substantially Equivalent on 2025-12-30. Applicant: Lucas Lifecare.
Clearance details
- Applicant
- Lucas Lifecare
- Product code
- Code FLE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Janesville, WI, US
Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.