Cleared Traditional

CURITY CURAD BANDAGES (K810126) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K810126 · The Kendal Co. · General & Plastic Surgery device
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Feb 1981
Decision
18d
Days
Class 1
Risk

K810126 is an FDA 510(k) clearance for the CURITY CURAD BANDAGES. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on February 6, 1981 after a review of 18 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 The Kendal Co. devices

Submission Details

510(k) Number K810126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1981
Decision Date February 06, 1981
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 22
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K810126.
TEGADERM TRANSPARENT DRESSING
K811291 · 3M Company · Jun 1981
BAND-AID KITCHEN ASSORTMENT
K810623 · Johnson & Johnson Professionals, Inc. · Mar 1981
SCOTCH BRAND ADHESIVE TAPE
K810580 · 3M Company · Mar 1981
JOHNSON & JOHNSON ADHESIVE FILM DRESSING
K810053 · Johnson & Johnson Professionals, Inc. · Jan 1981
3M HI-STRENGTH MED. TAPE #1534
K802242 · 3M Company · Sep 1980
ELASTIC ADHESIVE BANDAGES(STERILE)
K801794 · Smith & Nephew, Inc. · Aug 1980