510(k) Report

FDA applicant

Karmel Medical Acoustic Technologies, Ltd.

Tirat Hacarmel, IL1 decision1998–19980 recalls

FDA records 1 decision for Karmel Medical Acoustic Technologies, Ltd. (Tirat Hacarmel, IL) in 1998: 1 510(k) clearance. All are in product code BZM (Calculator, Pulmonary Function Interpretor…). 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 Karmel Medical Acoustic Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karmel Medical Acoustic Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Karmel Medical Acoustic Technologies, Ltd. 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?

  • BZMCalculator, Pulmonary Function Interpretor (Diagnostic)1decision

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.

  • K980878Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 19982cite it

What has FDA decided for it lately?

  • K980878Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998

The one decision as Karmel Medical Acoustic Technologies, Ltd. →