Cleared Traditional

K162610 - NEXA Negative Pressure Wound Therapy System

K162610 is an FDA 510(k) clearance for NEXA Negative Pressure Wound Therapy System, manufactured by Nexa Medical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K162610 · Nexa Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
262d
Days
Class 2
Risk

K162610 is an FDA 510(k) clearance for the NEXA Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Nexa Medical , Ltd. (Bournemouth, GB). The FDA issued a Cleared decision on June 8, 2017 after a review of 262 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Nexa Medical , Ltd. devices

FDA 510(k) Submission Details - K162610

510(k) Number K162610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date June 08, 2017
Days to Decision 262 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 115d · This submission: 262d
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 147
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K162610.
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
K172519 · 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