510(k) Report

FDA applicant

Sphygmetrics, Inc.

Mchenry, IL2 decisions1980–19800 recalls

FDA records 2 decisions for Sphygmetrics, Inc. (Mchenry, IL) in 1980: 2 510(k) clearances. Most are in product codes DXW (System, Phonocatheter, Intracavitary) and DXN (System, Measurement, Blood-Pressure…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Sphygmetrics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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