Cleared Traditional

K833954 - MELOLITE

K833954 is an FDA 510(k) clearance for MELOLITE, manufactured by Smith & Nephew, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K833954 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
124d
Days
Class 1
Risk

K833954 is an FDA 510(k) clearance for the MELOLITE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 124 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K833954

510(k) Number K833954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date March 19, 1984
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 89
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K833954.
MEDICAL ADHESIVE FOAM TAPE
K840448 · Lectec Corp. · Oct 1984
SKIN TECH. ISOTEX 86L
K840609 · Lectec Corp. · Oct 1984
MICROPOROUS MED. ADHESIVE TAPE
K840447 · Lectec Corp. · Aug 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984
DRESS, SURGICAL ADHESIVE
K833590 · Lectec Corp. · Jan 1984
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833731 · American Medical Disposable, Inc. · Jan 1984