Cleared Traditional

Lexa MINI (RIS-303, RIS-305) (K233504) - FDA 510(k) Clearance

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

K233504 · W&H Sterilization S.R.L. · General Hospital
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Feb 2024
Decision
100d
Days
Class 2
Risk

K233504 is an FDA 510(k) clearance for the Lexa MINI (RIS-303, RIS-305). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by W&H Sterilization S.R.L. (Brusaporto, IT). The FDA issued a Cleared decision on February 8, 2024 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 W&H Sterilization S.R.L. devices

Submission Details

510(k) Number K233504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2023
Decision Date February 08, 2024
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
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 Peers - FLE Sterilizer, Steam

All 61
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K233504.
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Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
K233026 · Midmark Corporation · Apr 2024
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · Primus Sterilizer Company, LLC · Dec 2023
T-Top 10 & T-Top T-Top 11
K232658 · Tuttnauer U.S.A Co, Ltd. · Nov 2023
AMSCO 600 Steam Sterilizer
K232485 · Steris · Sep 2023