Cleared Traditional

K864124 - SPAND-GEL GRANULATED GEL

K864124 is an FDA 510(k) clearance for SPAND-GEL GRANULATED GEL, manufactured by Medi-Tech Intl. Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K864124 · Medi-Tech Intl. Corp. · General & Plastic Surgery device
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Nov 1986
Decision
36d
Days
Class 1
Risk

K864124 is an FDA 510(k) clearance for the SPAND-GEL GRANULATED GEL. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Medi-Tech Intl. Corp. (Brooklyn, US). The FDA issued a Cleared decision on November 26, 1986 after a review of 36 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 Medi-Tech Intl. Corp. devices

FDA 510(k) Submission Details - K864124

510(k) Number K864124 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 21, 1986
Decision Date November 26, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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 148
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K864124.
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
K900127 · Ferris Mfg. Corp. · May 1990
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
K895819 · Medi-Tech, Inc. · Nov 1989
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
PREP-SITE PROTECTIVE DRESSING WIPE
K811625 · Acme United Corp. · Jul 1981
HYDRON WOUND DRESSING KIT
K811446 · National Patent Development Corp. · Jun 1981