Cleared Traditional

K864117 - SUPPORT ARM (FDA 510(k) Clearance)

K864117 · Leonard Medical, Inc. · Neurology device
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Nov 1986
Decision
13d
Days
-
Risk

K864117 is an FDA 510(k) clearance for the SUPPORT ARM.

Submitted by Leonard Medical, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Leonard Medical, Inc. devices

Submission Details

510(k) Number K864117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date November 03, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 148d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -