Cleared Traditional

K021238 - FRYE ADJUSTING INSTRUMENT

K021238 · Frye Health Systems · Physical Medicine device
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Oct 2002
Decision
174d
Days
-
Risk

K021238 is an FDA 510(k) clearance for the FRYE ADJUSTING INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Frye Health Systems (Mesa, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 174 days - an extended review cycle.

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. Standard predicate reliance. 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 - K021238

510(k) Number K021238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2002
Decision Date October 09, 2002
Days to Decision 174 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
59d slower than avg
Panel avg: 115d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

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