Cleared Traditional

K801794 - ELASTIC ADHESIVE BANDAGES(STERILE)

K801794 is an FDA 510(k) clearance for ELASTIC ADHESIVE BANDAGES(STERILE), 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 15-day FDA review.

K801794 · Smith & Nephew, Inc. · General & Plastic Surgery device
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Aug 1980
Decision
15d
Days
Class 1
Risk

K801794 is an FDA 510(k) clearance for the ELASTIC ADHESIVE BANDAGES(STERILE). 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 August 13, 1980 after a review of 15 days - a notably fast clearance 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: 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, Inc. devices

FDA 510(k) Submission Details - K801794

510(k) Number K801794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1980
Decision Date August 13, 1980
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 K801794.
ORTHOPEDIC PADDING
K802795 · Secol Co. · Dec 1980
3M HI-STRENGTH MED. TAPE #1534
K802242 · 3M Company · Sep 1980
FIRST AID BANDAGE CAT.#198 OR 199
K802013 · Pollak (Intl.), Ltd. · Sep 1980
LEUKOPOR
K792666 · Beiersdorf, Inc. · Jan 1980
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE
K792102 · National Patent Development Corp. · Nov 1979
HYPO-ALLERGENIC PAPER ADHESIVE TAPE
K792103 · National Patent Development Corp. · Nov 1979