Cleared Traditional

K991695 - DYNAREX NON-WOVEN SPONGE

K991695 is an FDA 510(k) clearance for DYNAREX NON-WOVEN SPONGE, manufactured by Dynarex Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K991695 · Dynarex Corp. · General & Plastic Surgery device
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Jul 1999
Decision
58d
Days
Class 1
Risk

K991695 is an FDA 510(k) clearance for the DYNAREX NON-WOVEN SPONGE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on July 15, 1999 after a review of 58 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 Dynarex Corp. devices

FDA 510(k) Submission Details - K991695

510(k) Number K991695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date July 15, 1999
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
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 91
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K991695.
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
FERRIS POLYOSTOMY STERILE WOUND DRESSING
K991729 · Ferris Mfg. Corp. · Aug 1999
DYNAREX DRAIN SPONGE
K991694 · Dynarex Corp. · Jul 1999
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
K990906 · Ferris Mfg. Corp. · Apr 1999
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
K984539 · Ferris Mfg. Corp. · Mar 1999
ASKINA HYDROCOLLOID/THIN
K973227 · B.Braun Medical, Inc. · Jan 1999