Cleared Traditional

K080315 - DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY

K080315 · 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
Apr 2008
Decision
77d
Days
-
Risk

K080315 is an FDA 510(k) clearance for the DERMA SCIENCES 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 April 23, 2008 after a review of 77 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 - K080315

510(k) Number K080315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2008
Decision Date April 23, 2008
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 K080315.
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · Medline Industries, Inc. · Apr 2008
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS
K073547 · Anacapa Technologies, Inc. · Apr 2008
ELTA ADVANCED WOUND WASH
K073610 · Swiss American Products, Inc. · Apr 2008
TETRIX CREAM
K071483 · Coria Laboratories, Ltd. · Apr 2008
RADIO BIOAQUACARE
K080471 · Bioartificial Gel Technologies (Bagtech), Inc. · Mar 2008
COLLAWOUND HYDROGEL
K071557 · Collamatrix Co., Inc. · Feb 2008
K080315 · DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Download PDF FDA Summary Derma Sciences, Inc.