Cleared Traditional

K250168 - Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250168 · Lucas Lifecare · General Hospital
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Dec 2025
Decision
343d
Days
Class 2
Risk

K250168 is an FDA 510(k) clearance for the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Lucas Lifecare (Janesville, US). The FDA issued a Cleared decision on December 30, 2025 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lucas Lifecare devices

Submission Details

510(k) Number K250168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 128d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Lourdes Lifecare
Anand Vangala

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K250168.
Enbio PRO
K260254 · Enbio Group AG · Feb 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · Maquet GmbH (A Getinge Group Company) · Jan 2026
Cassette Autoclave (ACA5)
K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · Aug 2025
Steam Sterilizer (2545D)
K243994 · Ningbo Ican Machines Co., Ltd. · Jun 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · Fort Defiance Industries, LLC · Mar 2025
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
K233026 · Midmark Corporation · Apr 2024