Cleared Traditional

BAND-AID BRAND OF ADHESIVE BANDAGES (K770081) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K770081 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Mar 1977
Decision
54d
Days
Class 1
Risk

K770081 is an FDA 510(k) clearance for the BAND-AID BRAND OF ADHESIVE BANDAGES. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on March 9, 1977 after a review of 54 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K770081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1977
Decision Date March 09, 1977
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPX Strip, Adhesive, Closure, Skin
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 - FPX Strip, Adhesive, Closure, Skin

All 8
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K770081.
SUTURELESS SKIN CLOSURE
K780565 · Abbott Laboratories · Jul 1978
CLOTH ADHESIVE TAPE
K772020 · Johnson & Johnson Professionals, Inc. · Nov 1977
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K770533 · Johnson & Johnson Professionals, Inc. · Jun 1977
BANDAGE, PLASTIC & SHEER
K770339 · Johnson & Johnson Professionals, Inc. · Feb 1977
SUB. OF DIACETONE ACRYLAMIDE
K770180 · Johnson & Johnson Professionals, Inc. · Feb 1977