510(k) Report

FDA applicant

Kaz USA, Inc., A Helen of Troy Company

Marlborough, MA8 decisions2016–20220 recalls

FDA records 8 decisions for Kaz USA, Inc., A Helen of Troy Company (Marlborough, MA) from 2016 to 2022: 8 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and QDD (Self-Fitting Air-Conduction Hearing Aid…). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 184 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 4 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 Kaz USA, Inc., A Helen of Troy Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 22017: 12018: 32020: 12022: 1
2016high 3 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Kaz USA, Inc., A Helen of Troy Company’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 Thermometer7decisions
  • QDDSelf-Fitting Air-Conduction Hearing Aid, Prescription1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 134 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 184 days; 6 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 4 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.

  • K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 201710cite it
  • K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 20222cite it
  • K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 20181cites it
  • K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 20181cites it
  • K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 20161cites it

What has FDA decided for it lately?

  • K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022
  • K193213Vicks VNT200 No Touch Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2020
  • K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
  • K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
  • K181015Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
  • K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company · 2017
  • K161933The Braun ThermoScan® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
  • K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016

All 8 as Kaz USA, Inc., A Helen of Troy Company →