Cleared Traditional

STOCKINETTE, STERILE TWO PLY W/PULL TABS (K801532) - FDA 510(k) Clearance

Class I General Hospital device.

K801532 · The Owenby Co. · General Hospital
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Jul 1980
Decision
27d
Days
Class 1
Risk

K801532 is an FDA 510(k) clearance for the STOCKINETTE, STERILE TWO PLY W/PULL TABS. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by The Owenby Co. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 27 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 The Owenby Co. devices

Submission Details

510(k) Number K801532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1980
Decision Date July 28, 1980
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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.