510(k) Report

FDA applicant

Kaz, Inc.

Washington, D.C., DC2 decisions1995–20111 recall

FDA records 2 decisions for Kaz, Inc. (Washington, D.C., DC) from 1995 to 2011: 2 510(k) clearances. Most are in product codes KFZ (Humidifier, Non-Direct Patient Interface…) and FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

How often FDA has decided Kaz, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like 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?

  • KFZHumidifier, Non-Direct Patient Interface (Home-Use)1decision
  • 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 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.

  • K103839Behind Ear Gentle Touch ThermometerKaz, Inc. · 20111cites it

What has FDA decided for it lately?

  • K103839Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011
  • K950116Therasteam Personal Steam InhalerKaz, Inc. · 19951 recall

All 2 as Kaz, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K950116VAPORIZER VICKS 1.5GAL Item Number: 2354942Mar 16, 2021Class II