510(k) Report

FDA applicant

Iqteq Development

Cape Town, Western Cape, ZA1 decision2003–20030 recalls

FDA records 1 decision for Iqteq Development (Cape Town, Western Cape, ZA) in 2003: 1 510(k) clearance. All are in product code BZG (Spirometer, Diagnostic). 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 Iqteq Development’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Iqteq Development since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iqteq Development 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, Diagnostic1decision

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.

  • K020102Iqteq SpirometerIqteq Development · 20031cites it

What has FDA decided for it lately?

  • K020102Iqteq SpirometerIqteq Development · 2003

The one decision as Iqteq Development →