Cleared Traditional

K152970 - Dynarex Xeroform Petrolatum Dressing

K152970 · Dynarex Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K152970

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 115d · This submission: 361d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 539
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K152970.
PolyPlex Wound Dressing
K160872 · Global Health Solutions, LLC · Nov 2016
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
Xonrid Gel
K152533 · Helsinn Healthcare SA · Oct 2016
Atteris Antimicrobial Skin Protectant
K161212 · Rochal Industries, LLC · Sep 2016
DONASORB SILVER WOUND DRESSING
K153565 · Virchow Biotech Pvt, Ltd. · Sep 2016
ACTICOAT Surgical Dressing
K153723 · Smith & Nephew Medical Limited · Sep 2016