Cleared Traditional

K820134 - VIGILON PRIMARY WOUND DRESSING, STERILE

K820134 is an FDA 510(k) clearance for VIGILON PRIMARY WOUND DRESSING, manufactured by C.R. Bard, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

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.

FDA 510(k) Submission Details - K820134

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.

KMF Device Classification - Class 1, General Controls

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 220
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K820134.
EXUSORB(TM) GEL DRESSING
K895606 · Controlled Therapeutics Corp. · Oct 1989
SPAND-GEL GRANULATED GEL
K864124 · Medi-Tech Intl. Corp. · Nov 1986
SKIN-LITE
K843300 · Guardian Chemical · Nov 1984
PREP-SITE PROTECTIVE DRESSING WIPE
K811625 · Acme United Corp. · Jul 1981
HYDRON WOUND DRESSING KIT
K811446 · National Patent Development Corp. · Jun 1981
CLINIGUARD STERILE
K810240 · Clinipad Corp. · Feb 1981
K820134 · VIGILON PRIMARY WOUND DRESSING, STERILE
Download PDF C.R. Bard, Inc.