Cleared Traditional

K896733 - VACCON

K896733 is the FDA 510(k) clearance for VACCON by Unoplast A/S. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K896733 · Unoplast A/S · General & Plastic Surgery device
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Feb 1990
Decision
63d
Days
Class 1
Risk

K896733 is an FDA 510(k) clearance for the VACCON. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Unoplast A/S (Denmark, DK). The FDA issued a Cleared decision on February 1, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Unoplast A/S devices

Submission Details

510(k) Number K896733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1989
Decision Date February 01, 1990
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 35
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K896733.
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
DUODERM* ADHESIVE COMPRESSION BANDAGE
K900447 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · Quinton, Inc. · Oct 1989
COMFEEL TRANSPARENT DRESSING
K894916 · Coloplast A/S · Sep 1989
ACTIDERM (TM) DERMATOLOGICAL PATCH
K895376 · Convatec, A Division of E.R. Squibb & Sons · Sep 1989