510(k) Report

FDA applicant

Frye Health Systems

Mesa, AZ1 decision2002–20020 recalls

FDA records 1 decision for Frye Health Systems (Mesa, AZ) in 2002: 1 510(k) clearance. All are in product code LXM (Manipulator, Plunger-Like Joint). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Frye Health Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Frye Health Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Frye Health Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LXMManipulator, Plunger-Like Joint1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021238Frye Adjusting InstrumentFrye Health Systems · 20021cites it

What has FDA decided for it lately?

  • K021238Frye Adjusting InstrumentFrye Health Systems · 2002

The one decision as Frye Health Systems →

Other applicant names beginning “Frye”

FDA records each applicant name separately; these may or may not be the same firm.

Frye Electronics, Inc. 13