Cleared Traditional

INTEGRATOR (K950646) - FDA 510(k) Clearance

K950646 · Moyco Union Broach, Div., Moyco Technologies, Inc. · Physical Medicine device
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Apr 1996
Decision
442d
Days
-
Risk

K950646 is an FDA 510(k) clearance for the INTEGRATOR. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Moyco Union Broach, Div., Moyco Technologies, Inc. (York, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Moyco Union Broach, Div., Moyco Technologies, Inc. devices

Submission Details

510(k) Number K950646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date April 30, 1996
Days to Decision 442 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 115d · This submission: 442d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXM Manipulator, Plunger-like Joint
Device Class -