Cleared Traditional

K202783 - Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing (FDA 510(k) Clearance)

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

K202783 · Smith & Nephew Medical Limited · General & Plastic Surgery device

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Jan 2022

Decision

479d

Days

Class 2

Risk

K202783 is an FDA 510(k) clearance for the Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dr.... 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 January 14, 2022 after a review of 479 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number	K202783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 22, 2020
Decision Date	January 14, 2022
Days to Decision	479 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

365d slower than avg

Panel avg: 114d · This submission: 479d

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.