Cleared Traditional

K082103 - LTM WOUND DRESSING

K082103 · Lifecell Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
75d
Days
-
Risk

K082103 is an FDA 510(k) clearance for the LTM WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Lifecell Corp. (Branchburg, US). The FDA issued a Cleared decision on October 8, 2008 after a review of 75 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 - K082103

510(k) Number K082103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2008
Decision Date October 08, 2008
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 184
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K082103.
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · Tei Biosciences, Inc. · Dec 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL
K081724 · Applied Nutritionals · Oct 2008
COLLIEVA
K081782 · Innocoll Pharmaceuticals · Sep 2008
NOCC HYDROPHILIC WOUND DRESSING
K080010 · Kytogenics, Inc. · Mar 2008
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
K082103 · LTM WOUND DRESSING
Download PDF FDA Summary Lifecell Corp.