Cleared Traditional

K915358 - PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH

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

K915358 · Medtronic Vascular · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K915358

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.

KGX Device Classification - Class 1, General Controls

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 185
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K915358.
TRICOPLAST
K921760 · Beiersdorf, Inc. · Aug 1992
TTL MEDICATED DRESSING
K914733 · Medimix Products, Inc. · Jul 1992
STRETCH WRAP
K915446 · Sun Glitz Corp. · May 1992
MARION WINDOW
K920182 · Tnt Moberg Intl. , Ltd. · Mar 1992
SURGICAL CLOTH TAPE (HEALRITE)
K914596 · Industrias Tuk, S.A. DE C.V. · Mar 1992
SURGICAL MICROPOROUS TAPE (MICROCEL)
K914597 · Industrias Tuk, S.A. DE C.V. · Mar 1992
K915358 · PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
Download PDF FDA Summary Medtronic Vascular