Cleared Traditional

K053095 - HONEY ALGINATE DRESSING

K053095 · Derma Sciences Canada, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
616d
Days
-
Risk

K053095 is an FDA 510(k) clearance for the HONEY ALGINATE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences Canada, Inc. (Toronto, Orntario, CA). The FDA issued a Cleared decision on July 12, 2007 after a review of 616 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.

View all Derma Sciences Canada, Inc. devices

FDA 510(k) Submission Details - K053095

510(k) Number K053095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2005
Decision Date July 12, 2007
Days to Decision 616 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
501d slower than avg
Panel avg: 115d · This submission: 616d
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K053095.
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
K063805 · Nucryst Pharmaceuticals, Inc. · Jul 2007
SILVER ALGINATE II WOUND DRESSING
K070581 · Advanced Medical Solutions Limited · Jul 2007
MEPILEX AG DRESSING
K071354 · Monlycke Health Care · Jul 2007
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
K070333 · Acrymed, Inc. · Jul 2007
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
K063063 · Medical Molecular Therapuetics, LLC · Jul 2007
MP 719
K070557 · Marine Polymer Technologies, Inc. · May 2007