Cleared Traditional

K840448 - MEDICAL ADHESIVE FOAM TAPE

K840448 is an FDA 510(k) clearance for MEDICAL ADHESIVE FOAM TAPE, manufactured by Lectec Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K840448 · Lectec Corp. · General & Plastic Surgery device
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Oct 1984
Decision
273d
Days
Class 1
Risk

K840448 is an FDA 510(k) clearance for the MEDICAL ADHESIVE FOAM TAPE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Lectec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 273 days - an extended review cycle.

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 Lectec Corp. devices

FDA 510(k) Submission Details - K840448

510(k) Number K840448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date October 31, 1984
Days to Decision 273 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
158d slower than avg
Panel avg: 115d · This submission: 273d
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 78
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K840448.
LEUKOFLEX SURGICAL TAPE
K843876 · Beiersdorf, Inc. · Feb 1985
DISPOSABLE LATEX BANDAGE
K842301 · Inmed Corp. · Nov 1984
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833731 · American Medical Disposable, Inc. · Jan 1984