Cleared Traditional

K133279 - MEDIHONEY WOUND DRESSINGS

K133279 · Derma Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
609d
Days
-
Risk

K133279 is an FDA 510(k) clearance for the MEDIHONEY WOUND DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (Toronto, Orntario, CA). The FDA issued a Cleared decision on June 25, 2015 after a review of 609 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K133279

510(k) Number K133279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2013
Decision Date June 25, 2015
Days to Decision 609 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
494d slower than avg
Panel avg: 115d · This submission: 609d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K133279.
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K143335 · Roosin Medical Devices Co., Ltd. · Jun 2015
K133279 · MEDIHONEY WOUND DRESSINGS
Download PDF FDA Summary Derma Sciences, Inc.