Cleared Traditional

K850133 - VENI-GARD AP & TPN

K850133 is the FDA 510(k) clearance for VENI-GARD AP & TPN by Consolidated Medical Equipment, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

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 74
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K850133.
PLASTELAST AND/OR ELASTOPLASTE
K854006 · Cp Medical · Nov 1985
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853820 · Abco Dealers, Inc. · Oct 1985
SHEER ADHESIVE BANDAGES, STERILE
K850529 · Abco Dealers, Inc. · May 1985
LEUKOFIX R
K843873 · Beiersdorf, Inc. · Feb 1985
LEUKOPOR SURGICAL TAPE
K843874 · Beiersdorf, Inc. · Feb 1985
LEUKOSILK
K843875 · Beiersdorf, Inc. · Feb 1985