510(k) Report

FDA applicant

Pinmed, Inc.

Pittsburg, PA1 decision2006–20060 recalls

FDA records 1 decision for Pinmed, Inc. (Pittsburg, PA) in 2006: 1 510(k) clearance. All are in product code DXH (Transmitters And Receivers…). 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 Pinmed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pinmed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pinmed, 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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K061977Pelex-04 Wireless Electrocardiograph with Software AccessoriesPinmed, Inc. · 20061cites it

What has FDA decided for it lately?

  • K061977Pelex-04 Wireless Electrocardiograph with Software AccessoriesPinmed, Inc. · 2006

The one decision as Pinmed, Inc. →