Cleared Traditional

CUTICOVER SKIN BARRIER DEVICE (K042955) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K042955 · D & D Holdings, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
601d
Days
Class 1
Risk

K042955 is an FDA 510(k) clearance for the CUTICOVER SKIN BARRIER DEVICE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by D & D Holdings, LLC (Nashville, US). The FDA issued a Cleared decision on June 19, 2006 after a review of 601 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all D & D Holdings, LLC devices

Submission Details

510(k) Number K042955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2004
Decision Date June 19, 2006
Days to Decision 601 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
486d slower than avg
Panel avg: 115d · This submission: 601d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 221
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