Cleared Traditional

K190028 - UNO 30

K190028 is the FDA 510(k) clearance for UNO 30 by Genadyne Biotechnologies. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K190028 · Genadyne Biotechnologies · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
373d
Days
Class 2
Risk

K190028 is an FDA 510(k) clearance for the UNO 30. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Genadyne Biotechnologies (Hicksville, US). The FDA issued a Cleared decision on January 15, 2020 after a review of 373 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 devices

Submission Details

510(k) Number K190028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2019
Decision Date January 15, 2020
Days to Decision 373 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
258d slower than avg
Panel avg: 115d · This submission: 373d
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 K190028.
Kendall NPWT Incision Management Dressing Kit
K191101 · Cardinalhealth · Jul 2020
ACTIV.A.C. Negative Pressure Wound Therapy System
K201571 · Kci USA, Inc. · Jul 2020
V.A.C. DERMATAC Drape
K200390 · Kci USA, Inc. · May 2020
PICO 14 Single Use Negative Pressure Wound Therapy System
K191760 · Smith & Nephew Medical Limited · Dec 2019
PREVENA PLUS Incision Management System (No Ag)
K190697 · Kci USA, Inc. · Nov 2019
Foryou NPWT Dressing Kit
K190119 · 4l Health Co., Ltd. · Nov 2019