510(k) Report

FDA applicant

Blazie Engineering, Inc.

Forest Hill, MD1 decision1995–19950 recalls

FDA records 1 decision for Blazie Engineering, Inc. (Forest Hill, MD) in 1995: 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 Blazie Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Blazie Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Blazie Engineering, 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?

  • FLLContinuous Measurement Thermometer1decision

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.

  • K935466Clinical Voice ThermometerBlazie Engineering, Inc. · 19951cites it

What has FDA decided for it lately?

  • K935466Clinical Voice ThermometerBlazie Engineering, Inc. · 1995

The one decision as Blazie Engineering, Inc. →