Cleared Traditional

K081584 - DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY

K081584 · 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 2008
Decision
14d
Days
-
Risk

K081584 is an FDA 510(k) clearance for the DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 19, 2008 after a review of 14 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.

FDA 510(k) Submission Details - K081584

510(k) Number K081584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2008
Decision Date June 19, 2008
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 K081584.
SILVER ANTIMICROBIAL WOUND GEL
K073197 · Advanced Medical Solutions Limited · Aug 2008
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
K080497 · Derma Sciences Canada, Inc. · Jun 2008
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876 · B.Braun Medical, Inc. · Jun 2008
THERABOND ANTIMICROBIAL BARRIER SYSTEMS
K073213 · Choice Therapeutics · May 2008
SURESKIN SILVER BANDAGES
K081274 · Euromed, Inc. · May 2008
MODIFICATION TO 3M TEGADERM CHG DRESSING
K080620 · 3M Company-3M Health Care · May 2008
K081584 · DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Download PDF FDA Summary Derma Sciences, Inc.