510(k) Report

FDA applicant

Z7 International

Acton, CA1 decision2002–20020 recalls

FDA records 1 decision for Z7 International (Acton, CA) in 2002: 1 510(k) clearance. All are in product code FLL (Continuous Measurement Thermometer). 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, general hospital panel, where it files most

How often FDA has decided Z7 International’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Z7 International since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Z7 International 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?

  • FLLContinuous Measurement Thermometer1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K021048Thermometer Models ST8631Z7 International · 20024cite it

What has FDA decided for it lately?

  • K021048Thermometer Models ST8631Z7 International · 2002

The one decision as Z7 International →