Cleared Traditional

K153678 - PermeaDerm B

K153678 · Permeaderm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
231d
Days
-
Risk

K153678 is an FDA 510(k) clearance for the PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Permeaderm, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 8, 2016 after a review of 231 days - an extended review 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: 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 Permeaderm, Inc. devices

FDA 510(k) Submission Details - K153678

510(k) Number K153678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date August 08, 2016
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
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 261
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K153678.
ACTICOAT Surgical Dressing
K153723 · Smith & Nephew Medical Limited · Sep 2016
Exufiber Ag+
K160379 · Molnlycke Health Care Us, LLC · Aug 2016
LUOFUCON Silicone Ag foam dressing
K160022 · Huizhou Foryou Medical Devices Co., Ltd. · Aug 2016
DURAFIBER Ag
K161289 · Smith & Nephew Medical Limited · Aug 2016
Medihoney Wound Gel
K150985 · Derma Sciences, Inc. · Nov 2015
MEDIHONEY WOUND DRESSINGS
K133279 · Derma Sciences, Inc. · Jun 2015