510(k) Report

FDA applicant

Fama Holdings International Corp

Parkland, FL1 decision2005–20050 recalls

FDA records 1 decision for Fama Holdings International Corp (Parkland, FL) in 2005: 1 510(k) clearance. All are in product code LKX (Device, Thermal, Hemorrhoids). 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 Fama Holdings International Corp’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fama Holdings International Corp since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fama Holdings International Corp 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?

  • LKXDevice, Thermal, Hemorrhoids1decision

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.

  • K042564Hemor-Rite CryotheraphyFama Holdings International Corp · 20051cites it

What has FDA decided for it lately?

  • K042564Hemor-Rite CryotheraphyFama Holdings International Corp · 2005

The one decision as Fama Holdings International Corp →