510(k) Report

FDA applicant

Tamarac Systems Corp.

Denver, CO3 decisions1989–19940 recalls

FDA records 3 decisions for Tamarac Systems Corp. (Denver, CO) from 1989 to 1994: 3 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BZH (Meter, Peak Flow, Spirometry). 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 Tamarac Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tamarac Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tamarac Systems Corp. 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?

  • BZGSpirometer, Diagnostic2decisions
  • BZHMeter, Peak Flow, Spirometry1decision

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.

  • K894997Presto Diagnostic SpirometerTamarac Systems Corp. · 19891cites it

What has FDA decided for it lately?

  • K940836Peaklog and Display SoftwareTamarac Systems Corp. · 1994
  • K894997Presto Diagnostic SpirometerTamarac Systems Corp. · 1989
  • K894680RS232 Flow Sensor and Software PackageTamarac Systems Corp. · 1989

All 3 as Tamarac Systems Corp. →