Cleared Special

K172519 - PICO Single Use Negative Pressure Wound Therapy System

K172519 is an FDA 510(k) clearance for PICO Single Use Negative Pressure Wound..., manufactured by Smith & Nephew Medical Limited. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 25-day FDA review.

K172519 · Smith & Nephew Medical Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Sep 2017
Decision
25d
Days
Class 2
Risk

K172519 is an FDA 510(k) clearance for the PICO Single Use Negative Pressure Wound Therapy System. 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 September 15, 2017 after a review of 25 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 Smith & Nephew Medical Limited devices

FDA 510(k) Submission Details - K172519

510(k) Number K172519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2017
Decision Date September 15, 2017
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
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 157
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K172519.
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · Smith & Nephew Medical Limited · Feb 2018
Occlusion Detection Dressing Kit
K171499 · Cardinalhealth · Sep 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · Smith & Nephew Medical Limited · Sep 2017
PICO Single Use Negative Pressure Wound Therapy System
K163387 · Smith & Nephew Medical Limited · Apr 2017
UNO Negative Pressure Wound Therapy System
K161599 · Genadyne Biotechnologies, Inc. · Apr 2017
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
K170088 · Medela AG · Apr 2017