Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer— 510(k) K250168

Name: FDA 510(k) clearance K250168
Creator: U.S. Food and Drug Administration
Published: 2025-12-30

Substantially Equivalent

Lucas Lifecare

FDA 510(k) clearance K250168 for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer, Substantially Equivalent on 2025-12-30. Applicant: Lucas Lifecare. Device class: 2.

Clearance details

Applicant: Lucas Lifecare
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2025-01-21
Decision date: 2025-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Janesville, WI, US

Download summary PDF View on FDA.gov ↗

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K250164 — Cassette Autoclave (ACA5)2025-08-14
K243994 — Steam Sterilizer (2545D)2025-06-06

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.