Cleared Traditional

K934839 - MESALT STERILE DRESSING

K934839 is an FDA 510(k) clearance for MESALT STERILE DRESSING, manufactured by Richard Hamer Assoc., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K934839 · Richard Hamer Assoc., Inc. · General & Plastic Surgery device
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Dec 1993
Decision
75d
Days
Class 1
Risk

K934839 is an FDA 510(k) clearance for the MESALT STERILE DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Richard Hamer Assoc., Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 22, 1993 after a review of 75 days - a notably fast clearance cycle.

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: 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 Richard Hamer Assoc., Inc. devices

FDA 510(k) Submission Details - K934839

510(k) Number K934839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date December 22, 1993
Days to Decision 75 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
40d faster than avg
Panel avg: 115d · This submission: 75d
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 75
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K934839.
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K926230 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
K933689 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1993
DUODERM EXTRA THIN CGF DRESSING
K925990 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993