Cleared Traditional

K926044 - MPM WET DRESSING (SALINE)

K926044 is an FDA 510(k) clearance for MPM WET DRESSING (SALINE), manufactured by Mpm Medical., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K926044 · Mpm Medical., Inc. · General & Plastic Surgery device
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Apr 1993
Decision
128d
Days
Class 1
Risk

K926044 is an FDA 510(k) clearance for the MPM WET DRESSING (SALINE). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Mpm Medical., Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Mpm Medical., Inc. devices

FDA 510(k) Submission Details - K926044

510(k) Number K926044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date April 08, 1993
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 140
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K926044.
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
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NASAL CAVITY WOUND DRESSING
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COMFEEL(R) WOUND DRESSING SD
K925376 · Coloplast A/S · Mar 1993
CURITY CALCIUM ALGINATE WOUND DRESSING
K925001 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
ATRAUM WOUND DRESSING--MODIFICATION
K922760 · Axiom Medical, Inc. · Oct 1992