Cleared Special

K201571 - ACTIV.A.C. Negative Pressure Wound Ther...

K201571 is an FDA 510(k) clearance for ACTIV.A.C. Negative Pressure Wound Ther..., manufactured by Kci USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 27-day FDA review.

K201571 · Kci USA, Inc. · General & Plastic Surgery device
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Jul 2020
Decision
27d
Days
Class 2
Risk

K201571 is an FDA 510(k) clearance for the ACTIV.A.C. Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 8, 2020 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kci USA, Inc. devices

FDA 510(k) Submission Details - K201571

510(k) Number K201571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date July 08, 2020
Days to Decision 27 days
Submission Type Special
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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

OMP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 138
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K201571.
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
K202157 · Smith & Nephew Medical Limited · Oct 2020
PocketDoc™ Micro Wound Therapy System
K200223 · Pensar Medical, LLC · Oct 2020
Kendall NPWT Incision Management Dressing Kit
K191101 · Cardinalhealth · Jul 2020
V.A.C. DERMATAC Drape
K200390 · Kci USA, Inc. · May 2020
UNO 30
K190028 · Genadyne Biotechnologies · Jan 2020
PICO 14 Single Use Negative Pressure Wound Therapy System
K191760 · Smith & Nephew Medical Limited · Dec 2019