510(k) Report

FDA applicant

Kaz USA, Inc (A Subsidiaryof Kaz Inc)

Southborough, MA3 decisions2010–20140 recalls

FDA records 3 decisions for Kaz USA, Inc (A Subsidiaryof Kaz Inc) (Southborough, MA) from 2010 to 2014: 3 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 4 predicates, 1 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 Subsidiaryof Kaz Inc)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 12011: 12014: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Kaz USA, Inc (A Subsidiaryof Kaz Inc) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kaz USA, Inc (A Subsidiaryof Kaz Inc)’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 Thermometer3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 1 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.

  • K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 20148cite it
  • K103800Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear ThermometersKaz USA, Inc (A Subsidiaryof Kaz Inc) · 20113cite it
  • K101747Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 20103cite it

What has FDA decided for it lately?

  • K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
  • K103800Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear ThermometersKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2011
  • K101747Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010

All 3 as Kaz USA, Inc (A Subsidiaryof Kaz Inc) →