Cleared Traditional

K801824 - BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K801824 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Aug 1980
Decision
20d
Days
Class 1
Risk

K801824 is an FDA 510(k) clearance for the BAND-AID BRAND FLEXIBLE FABRIC BANDAGE. Classified as Bag, Intestine (product code KGY), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4100 - 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K801824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1980
Decision Date August 20, 1980
Days to Decision 20 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
94d faster than avg
Panel avg: 114d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGY Bag, Intestine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4100
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.