Cleared Traditional

K014129 - PROMOGRAN MATRIX WOUND DRESSING

K014129 · Johnson & Johnson Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
59d
Days
-
Risk

K014129 is an FDA 510(k) clearance for the PROMOGRAN MATRIX WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Johnson & Johnson Medical, Ltd. (Somerville, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 59 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.

View all Johnson & Johnson Medical, Ltd. devices

FDA 510(k) Submission Details - K014129

510(k) Number K014129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2001
Decision Date February 14, 2002
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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 96
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K014129.
AVAGEN WOUND DRESSING
K022127 · Integra Lifesciences Corp. · Sep 2002
BILAYER MATRIX WOUND DRESSING
K021792 · Integra Lifesciences Corp. · Aug 2002
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000
SIGNADRESS DUODERM DRESSING
K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
K990086 · Integra Lifesciences Corp. · Mar 1999