510(k) Report

FDA applicant

Shore Medical, Inc.

Vista, CA1 decision1998–19980 recalls

FDA records 1 decision for Shore Medical, Inc. (Vista, CA) in 1998: 1 510(k) clearance. All are in product code BZT (Stethoscope, Esophageal, With Electrical…). 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 Shore Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shore Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shore Medical, 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?

  • BZTStethoscope, Esophageal, With Electrical Conductors1decision

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.

  • K982193Esophageal StethoscopeShore Medical, Inc. · 19981cites it

What has FDA decided for it lately?

  • K982193Esophageal StethoscopeShore Medical, Inc. · 1998

The one decision as Shore Medical, Inc. →