Cleared Traditional

K904411 - INTRASITE GEL (LABELING REVISION)

K904411 is an FDA 510(k) clearance for INTRASITE GEL (LABELING REVISION), manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K904411 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
61d
Days
Class 1
Risk

K904411 is an FDA 510(k) clearance for the INTRASITE GEL (LABELING REVISION). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 61 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 Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K904411

510(k) Number K904411 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1990
Decision Date November 26, 1990
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
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 147
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K904411.
COMFEEL CONTOUR DRESSING
K920925 · Coloplast A/S · May 1992
ALLEVLYN WOUND DRESSING, MODIFICATION
K914147 · Smith & Nephew United, Inc. · Feb 1992
FORTEX(TM) WOUND DRESSING
K914314 · Calgon Vestal Div. · Oct 1991
MODIFIED LYOFOAM WOUND DRESSINGS
K895764 · Acme United Corp. · Sep 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE GEL (LABELING REVISION)
K901878 · Smith & Nephew United, Inc. · Jun 1990