Cleared Traditional

K132936 - NOVOPORE DRESSING

K132936 is an FDA 510(k) clearance for NOVOPORE DRESSING, manufactured by Polynovo Biomaterials Pty, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K132936 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
167d
Days
Class 2
Risk

K132936 is an FDA 510(k) clearance for the NOVOPORE DRESSING. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Polynovo Biomaterials Pty, Ltd. (Austin, US). The FDA issued a Cleared decision on March 4, 2014 after a review of 167 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 Polynovo Biomaterials Pty, Ltd. devices

FDA 510(k) Submission Details - K132936

510(k) Number K132936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date March 04, 2014
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
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 213
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K132936.
EXTRICARE
K132225 · Devon Medical, Inc. · May 2014
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
K132004 · Creo Quality, LLC · May 2014
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
K133232 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Mar 2014
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
K133276 · Kci USA, Inc. · Nov 2013
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K132741 · Kci USA, Inc. · Nov 2013
KULAVAC
K122490 · CG Bio Co., Ltd. · Nov 2013