510(k) Report

FDA applicant

Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)

Southborough, MA1 decision2016–20162 recalls

FDA records 1 decision for Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) (Southborough, MA) in 2016: 1 510(k) clearance. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2024

2021: 12024: 1
2016high 1 (2021) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kaz USA, Inc (A Subsidiary of Helen of…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FLLContinuous Measurement Thermometer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K152748Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · 20164cite it

What has FDA decided for it lately?

  • K152748Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · 20162 recalls

The one decision as Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K152748Braun Thermoscan¿ PRO 6000 Ear ThermometerJun 13, 2024Class II
  • K152748Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of…Jul 20, 2021Class II