Cleared Traditional

K961662 - ADVANCED CARE HYDROPHILIC WOUND DRESSINGS

K961662 is an FDA 510(k) clearance for ADVANCED CARE HYDROPHILIC WOUND DRESSINGS, manufactured by Mariner Biomedical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K961662 · Mariner Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
44d
Days
Class 1
Risk

K961662 is an FDA 510(k) clearance for the ADVANCED CARE HYDROPHILIC WOUND DRESSINGS. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Mariner Biomedical, Inc. (Guilford, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 44 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 Mariner Biomedical, Inc. devices

FDA 510(k) Submission Details - K961662

510(k) Number K961662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date June 13, 1996
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 K961662.
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
K962740 · Medi-Flex Hospital Products, Inc. · Sep 1996
SORBCEL ALGINATE/CMC WOUND DRESSING
K962421 · Innovative Technologies , Ltd. · Jul 1996
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K961323 · Acme United Corp. · Jun 1996
ACTICOAT SILVER COATED DRESSING
K955453 · Westaim Technologies, Inc. · May 1996
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
K961452 · Acme United Corp. · May 1996
MULTIDEX PLUS HYDROPHILIC WOUND DRESSING
K955399 · Lange Medical Products, Inc. · Feb 1996