Cleared Traditional

K113772 - HPR EMOLLIENT FOAM

K113772 · Prugen IP Holdings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
49d
Days
-
Risk

K113772 is an FDA 510(k) clearance for the HPR EMOLLIENT FOAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Prugen IP Holdings, Inc. (Scottsdale, US). The FDA issued a Cleared decision on February 9, 2012 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prugen IP Holdings, Inc. devices

FDA 510(k) Submission Details - K113772

510(k) Number K113772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date February 09, 2012
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 265
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