Cleared Traditional

SHOULDER-HOLDER (K851206) - FDA 510(k) Clearance

K851206 · Biodynamic Technologies, Inc. · Orthopedic device
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Apr 1985
Decision
30d
Days
-
Risk

K851206 is an FDA 510(k) clearance for the SHOULDER-HOLDER.

Submitted by Biodynamic Technologies, Inc. (Arlington, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. 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 Biodynamic Technologies, Inc. devices

Submission Details

510(k) Number K851206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date April 25, 1985
Days to Decision 30 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -