Cleared Traditional

K223041 - Renasys Edge (66803126) (FDA 510(k) Clearance)

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

K223041 · Smith & Nephew Medical Limited · General & Plastic Surgery device

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Nov 2022

Decision

54d

Days

Class 2

Risk

K223041 is an FDA 510(k) clearance for the Renasys Edge (66803126). Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on November 22, 2022 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number	K223041 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 2022
Decision Date	November 22, 2022
Days to Decision	54 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

60d faster than avg

Panel avg: 114d · This submission: 54d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4780
Definition	For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.

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 & Plastic Surgery devices follow this clearance model.