510(k) Report

FDA applicant

Exergen Corp.

Washington, DC1 decision2001–20010 recalls

FDA records 1 decision for Exergen Corp. (Washington, DC) in 2001: 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 Exergen Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Exergen Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Exergen Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Exergen Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FLLContinuous Measurement Thermometer1decision

Who builds on its devices?

Later devices cite its devices 17 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.

  • K011291Temporalscanner Thermometer, SensortouchExergen Corp. · 200117cite it

What has FDA decided for it lately?

  • K011291Temporalscanner Thermometer, SensortouchExergen Corp. · 2001

The one decision as Exergen Corp. →