510(k) Report

FDA applicant

Uri Therm-X, Inc.

Champaign, IL1 decision1984–19840 recalls

FDA records 1 decision for Uri Therm-X, Inc. (Champaign, IL) in 1984: 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 Uri Therm-X, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uri Therm-X, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Uri Therm-X, 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 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.

  • K843381Uri TX-100 Multichannel ThermocoupleUri Therm-X, Inc. · 19842cite it

What has FDA decided for it lately?

  • K843381Uri TX-100 Multichannel ThermocoupleUri Therm-X, Inc. · 1984

The one decision as Uri Therm-X, Inc. →