Cleared Traditional

K895819 - MODIFIED LABELING TO THE SPAND-GEL GRAN...

K895819 is the FDA 510(k) clearance for MODIFIED LABELING TO THE SPAND-GEL GRAN... by Medi-Tech, Inc.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K895819 · Medi-Tech, Inc. · General & Plastic Surgery device
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Nov 1989
Decision
34d
Days
Class 1
Risk

K895819 is an FDA 510(k) clearance for the MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Medi-Tech, Inc. (Brooklyn, US). The FDA issued a Cleared decision on November 2, 1989 after a review of 34 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, Inc. devices

Submission Details

510(k) Number K895819 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 29, 1989
Decision Date November 02, 1989
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 47
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K895819.
COMFEEL WOUND DRESSING SD
K922466 · Coloplast A/S · Aug 1992
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
DRESSING, ENVIRON WOUND
K782008 · Abbott Laboratories · May 1979
KIMLON BEDGARD UNDERPAD
K790384 · Kimberly-Clark Corp. · Apr 1979