Cleared Traditional

Dynarex Xeroform Petrolatum Dressing (K152970) - FDA 510(k) Clearance

K152970 · Dynarex Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2016
Decision
361d
Days
-
Risk

K152970 is an FDA 510(k) clearance for the Dynarex Xeroform Petrolatum Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on October 3, 2016 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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 Dynarex Corporation devices

Submission Details

510(k) Number K152970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2015
Decision Date October 03, 2016
Days to Decision 361 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
246d slower than avg
Panel avg: 115d · This submission: 361d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 163
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K152970.
Microcyn Antimicrobial Hydrogel
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Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company · Feb 2013
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011