Cleared Traditional

Lexa MINI (RIS-303, RIS-305) (K223858) - FDA 510(k) Clearance

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

K223858 · W&H Sterilization S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
133d
Days
Class 2
Risk

K223858 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 May 5, 2023 after a review of 133 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 K223858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2022
Decision Date May 05, 2023
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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 K223858.
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
Sturdy Autoclave Super Microm
K231489 · Sturdy Industrial Co., Ltd. · Jun 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · Primus Sterilizer Company, LLC · Feb 2023
Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
K213545 · Steelco S.P.A. · Feb 2023
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
K222608 · Tuttnauer , Ltd. · Dec 2022