Cleared Traditional

K150960 - WoundPro Negative Pressure Wound Therapy System

K150960 is an FDA 510(k) clearance for WoundPro Negative Pressure Wound Therap..., manufactured by Pensar Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 601-day FDA review.

K150960 · Pensar Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
601d
Days
Class 2
Risk

K150960 is an FDA 510(k) clearance for the WoundPro Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Pensar Medical, LLC (Temecula, US). The FDA issued a Cleared decision on December 1, 2016 after a review of 601 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.

View all Pensar Medical, LLC devices

FDA 510(k) Submission Details - K150960

510(k) Number K150960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2015
Decision Date December 01, 2016
Days to Decision 601 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
486d slower than avg
Panel avg: 115d · This submission: 601d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 193
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K150960.
V.A.C.ULTA Negative Pressure Wound Therapy System
K162790 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Jan 2017
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
K161418 · Cardinalhealth · Jan 2017
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System
K160487 · Kci USA, Inc. · Dec 2016
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply
K161128 · Medela AG · Dec 2016
Avance Foam Dressing Kit - XL
K161935 · Molnlycke Health Care Us, LLC · Nov 2016
Avance Gauze Dressing Kits
K161948 · Molnlycke Health Care Us, LLC · Nov 2016