Cleared Traditional

K013462 - HYDROFERA BACTERIOSTATIC WOUND DRESSING

K013462 · Hydrofera, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
85d
Days
-
Risk

K013462 is an FDA 510(k) clearance for the HYDROFERA BACTERIOSTATIC WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on January 11, 2002 after a review of 85 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 Hydrofera, LLC devices

FDA 510(k) Submission Details - K013462

510(k) Number K013462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2001
Decision Date January 11, 2002
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 226
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K013462.
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · Coloplast Corp. · May 2004
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K022416 · Coloplast Corp. · Feb 2003
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
COMPEED PSORIASIS DRESSING
K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM DRESSING
K983163 · Coloplast Corp. · Dec 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998