Cleared Traditional

VIGILON PRIMARY WOUND DRESSING, STERILE (K820134) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K820134 · C.R. Bard, Inc. · General & Plastic Surgery device
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Feb 1982
Decision
18d
Days
Class 1
Risk

K820134 is an FDA 510(k) clearance for the VIGILON PRIMARY WOUND DRESSING, STERILE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982 after a review of 18 days - a notably fast clearance 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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K820134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1982
Decision Date February 05, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
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 K820134.
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Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc. · Jan 2018
DRESSING, ENVIRON WOUND
K782008 · Abbott Laboratories · May 1979
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406 · Abbott Laboratories · Sep 1978
HYDRON BURN DISPOSABLE DISPENSER SET
K780616 · Abbott Laboratories · Apr 1978