Cleared Traditional

K915358 - PROMEON HYDROGEL DRESSING #45 NONSTERIL...

K915358 is the FDA 510(k) clearance for PROMEON HYDROGEL DRESSING #45 NONSTERIL... by Medtronic Vascular. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K915358 · Medtronic Vascular · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
153d
Days
Class 1
Risk

K915358 is an FDA 510(k) clearance for the PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Medtronic Vascular (Brooklyn Center, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K915358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date April 28, 1992
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
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 68
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K915358.
DUODERM SUSTAINED COMPRESSION BANDAGE
K920675 · Convatec, A Division of E.R. Squibb & Sons · Aug 1992
ACRYLASTIC
K921759 · Beiersdorf, Inc. · Aug 1992
TRICOPLAST
K921760 · Beiersdorf, Inc. · Aug 1992
CANN-HOLD
K915057 · O.R. Concepts, Inc. · Mar 1992
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
K912518 · Convatec, A Division of E.R. Squibb & Sons · Sep 1991
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED
K912550 · Convatec, A Division of E.R. Squibb & Sons · Aug 1991