Cleared Traditional

K802785 - ELASTIC BANDAGE (FDA 510(k) Clearance)

Class I General Hospital device.

K802785 · Secol Co. · General Hospital
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Dec 1980
Decision
37d
Days
Class 1
Risk

K802785 is an FDA 510(k) clearance for the ELASTIC BANDAGE. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Secol Co. (Walker, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - the FDA general hospital 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 Secol Co. devices

Submission Details

510(k) Number K802785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date December 11, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 128d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
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.