Skip to content

New Vitajet

by Andrew V. Stadler

510(k) K851029

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851029 Date23 May 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KZE
Device Class
Class II
Regulation
21 CFR Part 880.5430
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The New Vitajet is a fluid injector, non-electrically powered device. It is designed for use in general hospital settings to administer fluids.

The device is supplied by Andrew V. Stadler and has FDA 510(k) clearance with decision code SESE. It is classified as a Class II medical device with product code KZE.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the New Vitajet used for?

    The New Vitajet is used to administer fluids in general hospital settings, providing a non-electrically powered solution for fluid injection.

  • Is the New Vitajet a single-use device?

    The device data does not specify if the New Vitajet is single-use or reusable, it is recommended to consult the manufacturer's instructions for use.

  • What is the regulatory status of the New Vitajet?

    The New Vitajet has FDA 510(k) clearance with decision code SESE, classified as a Class II medical device with product code KZE.

  • Who manufactures the New Vitajet?

    The New Vitajet is manufactured by Andrew V. Stadler.