Cleared Traditional

HYPERGEL PROTECTIVE WOUND GEL (K905439) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K905439 · Scott Health Care · General & Plastic Surgery device
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May 1991
Decision
176d
Days
Class 1
Risk

K905439 is an FDA 510(k) clearance for the HYPERGEL PROTECTIVE WOUND GEL. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Scott Health Care (Philadelphia, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 176 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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.

View all Scott Health Care devices

Submission Details

510(k) Number K905439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date May 29, 1991
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
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
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K905439.
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