Cleared Traditional

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

K250168 · Lucas Lifecare · General Hospital

Dec 2025

Decision

343d

Days

Class 2

Risk

About This 510(k) Submission

K250168 is an FDA 510(k) clearance for the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Lucas Lifecare (Janesville, US). The FDA issued a Cleared decision on December 30, 2025, 343 days after receiving the submission on January 21, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K250168 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2025
Decision Date	December 30, 2025
Days to Decision	343 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF