Cleared Traditional

K060832 - RETRO-TECH DRESSING

K060832 · Retro-Tech, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
351d
Days
-
Risk

K060832 is an FDA 510(k) clearance for the RETRO-TECH DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Retro-Tech, LLC (Irvine, US). The FDA issued a Cleared decision on March 13, 2007 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K060832

510(k) Number K060832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date March 13, 2007
Days to Decision 351 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
236d slower than avg
Panel avg: 115d · This submission: 351d
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 708
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K060832.
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · Argentum International, LLC · Mar 2007
SILVERLON ADHESIVE STRIP
K984205 · Argentum International, LLC · Mar 2007
HEALADEX-P
K063517 · Healagenics, Inc. · Feb 2007
EXSEPT WC WOUND CLEANSER
K061467 · Alcavis International, Inc. · Feb 2007
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER
K062559 · Laboratoires Urgo · Jan 2007
K060832 · RETRO-TECH DRESSING
Download PDF FDA Summary Retro-Tech, LLC