Cleared Traditional

FRYE ADJUSTING INSTRUMENT (K021238) - FDA 510(k) Clearance

K021238 · Frye Health Systems · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Frye Health Systems devices

Submission Details

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.

Device Classification

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