510(k) Report

FDA applicant

Pal Medical, Inc.

Orlando, FL1 decision1995–19950 recalls

FDA records 1 decision for Pal Medical, Inc. (Orlando, FL) in 1995: 1 510(k) clearance. All are in product code BWF (Spirometer, Therapeutic (Incentive)). No recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Pal Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pal Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pal Medical, Inc. 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?

  • BWFSpirometer, Therapeutic (Incentive)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K944412The BreatherPal Medical, Inc. · 19952cite it

What has FDA decided for it lately?

  • K944412The BreatherPal Medical, Inc. · 1995

The one decision as Pal Medical, Inc. →