Cleared Traditional

K780053 - BRACE, TENNIS ELBOW (FDA 510(k) Clearance)

Class I Physical Medicine device.

K780053 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Physical Medicine device
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Jan 1978
Decision
8d
Days
Class 1
Risk

K780053 is an FDA 510(k) clearance for the BRACE, TENNIS ELBOW. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on January 17, 1978 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K780053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1978
Decision Date January 17, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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.