Cleared Traditional

VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (K850133) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K850133 · Consolidated Medical Equipment, Inc. · General & Plastic Surgery device
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Feb 1985
Decision
45d
Days
Class 1
Risk

K850133 is an FDA 510(k) clearance for the VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Consolidated Medical Equipment, Inc. (Utica, US). The FDA issued a Cleared decision on February 28, 1985 after a review of 45 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 Consolidated Medical Equipment, Inc. devices

Submission Details

510(k) Number K850133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 28, 1985
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 19
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K850133.
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984