510(k) Report

FDA applicant

Valeo Corp.

Flagstaff, AZ3 decisions1998–20120 recalls

FDA records 3 decisions for Valeo Corp. (Flagstaff, AZ) from 1998 to 2012: 3 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Valeo Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Valeo Corp. 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 Thermometer3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K111463Valeo VT-601 Series IR ThermometerValeo Corp. · 20121cites it

What has FDA decided for it lately?

  • K111463Valeo VT-601 Series IR ThermometerValeo Corp. · 2012
  • K002562Pacifier Thermometer Models VT-901F, VT901CValeo Corp. · 2000
  • K982140Clinical Electronic ThermometerValeo Corp. · 1998

All 3 as Valeo Corp. →