Cleared Traditional

K180840 - UNO Negative Pressure Wound Therapy System

K180840 is the FDA 510(k) clearance for UNO Negative Pressure Wound Therapy System by Genadyne Biotechnologies, Inc.. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K180840 · Genadyne Biotechnologies, Inc. · General & Plastic Surgery device
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Nov 2018
Decision
245d
Days
Class 2
Risk

K180840 is an FDA 510(k) clearance for the UNO Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on November 30, 2018 after a review of 245 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 Genadyne Biotechnologies, Inc. devices

Submission Details

510(k) Number K180840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2018
Decision Date November 30, 2018
Days to Decision 245 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
130d slower than avg
Panel avg: 115d · This submission: 245d
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.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 100
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K180840.
PICO 7Y Single Use Negative Pressure Wound Therapy System
K182323 · Smith & Nephew Medical Limited · Jan 2019
Applied Tissue Technologies PWD™ Platform Wound Dressing
K182409 · Applied Tissue Technologies, LLC · Jan 2019
RENASYS Y-Connector
K181204 · Smith & Nephew Medical Limited · Jan 2019
Invia White Foam NPWT
K180415 · Medela AG · Nov 2018
AVELLE Negative Pressure Wound Therapy System
K180205 · Convatec Limited · Oct 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K180698 · Smith & Nephew Medical Limited · Aug 2018