Cleared Traditional

K790210 - STOCKINETTE

K790210 is the FDA 510(k) clearance for STOCKINETTE by The Owenby Co.. It is a Class 1 General Hospital device (product code FQM) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K790210 · The Owenby Co. · General Hospital
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Feb 1979
Decision
28d
Days
Class 1
Risk

K790210 is an FDA 510(k) clearance for the STOCKINETTE, TUBULAR UNBLEACHED. 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 February 27, 1979 after a review of 28 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 K790210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1979
Decision Date February 27, 1979
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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.

Regulatory Peers - FQM Bandage, Elastic

All 15
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K790210.
ANAGO DISP., ALL PURPOSE PATIENT REST.
K800197 · Anago, Inc. · Feb 1980
BINDAFIX
K791211 · Conphar, Inc. · Aug 1979
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979
TAPE, ELASTOPLAST ELASTIC TEAR
K781931 · Beiersdorf, Inc. · Dec 1978
BANDAGE
K780606 · Abco Dealers, Inc. · Apr 1978
BANDAGE, ELASTIC
K780231 · Biomet, Inc. · Feb 1978