Vitajet Jet Insulin Injection Device

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

510(k) Number

K843784 ↗

FDA Product Code

KZE

Device Class

Class II

Regulation

21 CFR Part 880.5430

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vitajet Insulin Jet Injection Device

  Class II

  FDA 510(k) K893215 Active Cleared 7 May 1990

• How does the Vitajet Jet Insulin Injection Device differ from traditional needle-based insulin injectors, and what are its key advantages?

  The Vitajet Jet Insulin Injection Device uses a jet injection mechanism powered by high-pressure fluid propulsion instead of a traditional needle. This eliminates the need for a sharp needle, which may reduce patient anxiety and potential needle-stick injuries for healthcare providers. It is designed for subcutaneous insulin delivery in clinical settings like hospitals, offering a non-electrically powered alternative that simplifies administration while maintaining sterility through pre-filled, single-use packaging.

• Is the Vitajet Jet Insulin Injection Device reusable, or is it intended for single-use only?

  The Vitajet Jet Insulin Injection Device is explicitly designed for single-use only. This aligns with standard aseptic practices in clinical settings, ensuring patient safety and sterility. Reuse is not recommended or supported by the manufacturer, as it could compromise the device’s performance or introduce contamination risks.

• What regulatory pathway was followed for FDA clearance of the Vitajet Jet Insulin Injection Device, and what does this mean for its use in hospitals?

  The device received FDA 510(k) clearance (K843784) under the Substantially Equivalent (SESE) determination, meaning it was deemed comparable to legally marketed devices already on the market. This clearance was granted under product code KZE for an Injector, Fluid, Non-Electrically Powered, with the General Hospital advisory committee overseeing the review. Clinically, this means it is approved for use in hospital settings where insulin administration is required, adhering to FDA standards for injectors.

• Are there multiple sizes or models of the Vitajet Jet Insulin Injection Device, and how are they differentiated?

  The device data lists multiple FEI numbers (e.g., 3002939152, 3009339779, etc.), which typically correspond to different registration numbers—suggesting there may be variations in batch or model identifiers. However, the provided details do not specify distinct sizes, dosages, or functional differences between these entries. For precise model differentiation (e.g., insulin dose capacity or nozzle design), consulting the manufacturer’s technical documentation or contacting Vitajet Industriae Comercioltda directly would be necessary.

• How should the Vitajet Jet Insulin Injection Device be stored, and are there any special handling instructions?

  Since the device is sterile and pre-filled, it should be stored according to standard aseptic protocols for single-use medical devices. The manufacturer’s instructions (not detailed here) would likely specify conditions like room temperature, protection from light, or moisture, and potentially expiration dates. As it is non-electrically powered and jet-based, no special electrical or mechanical storage precautions are noted beyond typical clinical storage for injectors. Always verify storage guidelines in the accompanying documentation.