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Vitajet Insulin Jet Injection Device

by Vitajet Industriae Comercioltda.

510(k) K893215

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 NumberK893215 Date7 May 1990ClearedStatusActive

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  • Withdrawn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, 18 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 Vitajet Insulin Jet Injection Device is a non-electrically powered injector classified as an Injector, Fluid under FDA regulation 880.5430. It delivers insulin via a jet injection mechanism, designed for subcutaneous administration without the need for needles or electricity, relying instead on pressurized fluid propulsion.

This device is intended for single-use in general hospital settings and has received FDA 510(k) clearance under K893215, classified as substantially equivalent (SESE). It is not sterilized for reuse and must be handled as a sterile, disposable medical instrument. No MRI safety information or additional size specifications are provided in the regulatory data.

Other devices from Vitajet Industriae Comercioltda.