510(k) Report

FDA applicant

Pn Medical

Orlando, FL1 decision1998–19980 recalls

FDA records 1 decision for Pn Medical (Orlando, FL) in 1998: 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 Pn Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pn Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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