Cleared Traditional

K925937 - WELLS LAMONT HANDAGES/MED WRAP DRESSINGS

K925937 is an FDA 510(k) clearance for WELLS LAMONT HANDAGES/MED WRAP DRESSINGS, manufactured by Wells Lamont Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K925937 · Wells Lamont Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
258d
Days
Class 1
Risk

K925937 is an FDA 510(k) clearance for the WELLS LAMONT HANDAGES/MED WRAP DRESSINGS. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Wells Lamont Corp. (Niles, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 258 days - an extended review 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: 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 Wells Lamont Corp. devices

FDA 510(k) Submission Details - K925937

510(k) Number K925937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1992
Decision Date August 09, 1993
Days to Decision 258 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
143d slower than avg
Panel avg: 115d · This submission: 258d
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 155
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K925937.
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
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
K930468 · 3M Health Care, Ltd. · Aug 1993
3M TEGASORB THIN HYDROCOLLOID DRESSING
K924280 · 3M Health Care, Ltd. · May 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993