Cleared Traditional

K991608 - DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

K991608 is an FDA 510(k) clearance for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING, manufactured by Dermaphylyx, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K991608 · Dermaphylyx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
71d
Days
Class 1
Risk

K991608 is an FDA 510(k) clearance for the DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dermaphylyx, Inc. (Arvada, US). The FDA issued a Cleared decision on July 20, 1999 after a review of 71 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 Dermaphylyx, Inc. devices

FDA 510(k) Submission Details - K991608

510(k) Number K991608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date July 20, 1999
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 139
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K991608.
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
K992032 · Acrymed, Inc. · Aug 1999
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
K991920 · Dermaphylyx, Inc. · Aug 1999
DERMAPHYLYX FOAM ISLAND DRESSING
K991933 · Dermaphylyx, Inc. · Jul 1999
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
K991609 · Dermaphylyx, Inc. · Jul 1999
DYNAREX DRAIN SPONGE
K991694 · Dynarex Corp. · Jul 1999
DYNAREX NON-WOVEN SPONGE
K991695 · Dynarex Corp. · Jul 1999