510(k) Report

FDA applicant

Vitajet Corp.

Laguna Hills, CA3 decisions1993–19960 recalls

FDA records 3 decisions for Vitajet Corp. (Laguna Hills, CA) from 1993 to 1996: 3 510(k) clearances. Most are in product codes KZE (Injector, Fluid, Non-Electrically Powered) and KZF (Device, Medical Examination, Ac Powered). 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 Vitajet Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vitajet Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vitajet 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?

  • KZEInjector, Fluid, Non-Electrically Powered2decisions
  • KZFDevice, Medical Examination, Ac Powered1decision

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.

  • K962625VitajetVitajet Corp. · 19961cites it

What has FDA decided for it lately?

  • K962625VitajetVitajet Corp. · 1996
  • K945548MedivaxVitajet Corp. · 1995
  • K924447VitapenVitajet Corp. · 1993

All 3 as Vitajet Corp. →

Other applicant names beginning “Vitajet”

FDA records each applicant name separately; these may or may not be the same firm.

Vitajet Industriae Comercioltda. 2