Cleared Traditional

K130666 - KHAN KINETIC TREATMENT (KKT-M2)

K130666 · Optima Health Solutions International Corporation · Physical Medicine device
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Jan 2014
Decision
317d
Days
-
Risk

K130666 is an FDA 510(k) clearance for the KHAN KINETIC TREATMENT (KKT-M2). Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Optima Health Solutions International Corporation (Vancouver, CA). The FDA issued a Cleared decision on January 23, 2014 after a review of 317 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K130666

510(k) Number K130666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date January 23, 2014
Days to Decision 317 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 115d · This submission: 317d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

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