510(k) Report

FDA applicant

Physio-Dyne Instrument Corp.

Massapequa, NY1 decision1989–19890 recalls

FDA records 1 decision for Physio-Dyne Instrument Corp. (Massapequa, NY) in 1989: 1 510(k) clearance. All are in product code BZC (Calculator, Pulmonary Function Data). 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 Physio-Dyne Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Physio-Dyne Instrument Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Physio-Dyne Instrument Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Physio-Dyne”

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