510(k) Report

FDA applicant

Biomedical Concepts, Inc.

White Plans, NY3 decisions1981–19870 recalls

FDA records 3 decisions for Biomedical Concepts, Inc. (White Plans, NY) from 1981 to 1987: 3 510(k) clearances. Most are in product codes BZT (Stethoscope, Esophageal, With Electrical…) and DQD (Stethoscope, Electronic). 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 Biomedical Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomedical Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomedical Concepts, 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 Conductors2decisions
  • DQDStethoscope, Electronic1decision

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.

  • K864858Lifesound (TM) Esophageal Stethoscope W/ThermistorBiomedical Concepts, Inc. · 19871cites it

What has FDA decided for it lately?

  • K864858Lifesound (TM) Esophageal Stethoscope W/ThermistorBiomedical Concepts, Inc. · 1987
  • K844804Lifesound - Electronic StethoscopeBiomedical Concepts, Inc. · 1985
  • K811928Lifesound Esophageal StethoscopeBiomedical Concepts, Inc. · 1981

All 3 as Biomedical Concepts, Inc. →