510(k) Report

FDA applicant

Physio-Dyne

Massapequa, NY1 decision1993–19930 recalls

FDA records 1 decision for Physio-Dyne (Massapequa, NY) in 1993: 1 510(k) clearance. All are in product code BZL (Computer, Oxygen-Uptake). 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’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Physio-Dyne since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Physio-Dyne 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?

  • BZLComputer, Oxygen-Uptake1decision

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.

  • K922660Physio-Dyne Easi - LabPhysio-Dyne · 19932cite it

What has FDA decided for it lately?

  • K922660Physio-Dyne Easi - LabPhysio-Dyne · 1993

The one decision as Physio-Dyne →

Other applicant names beginning “Physio-Dyne”

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

Physio-Control Corp. 97Physio Technology, Inc. 10Physio Systems, Inc. 3Physio Tronics Corp. 1Physio Designs, Inc. 1Physio-Dyne Industrument Corp. 1Physio-Dyne Instrument Corp. 1Physio, Inc. 1Physio Ventures, Inc. 1