Skip to content

Miniject Needle-Free Injection System, Model FG-01-001

by Biovalve Technologies, Inc.

510(k) K032976

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032976 Date16 Apr 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Biovalve Miniject Needle-Free Injection System, Model Fg-01-001
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, 1 Oct 2026

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

The Miniject Needle-Free Injection System, Model FG-01-001, is a non-electrically powered injector classified as an Injector, Fluid. It delivers fluid subcutaneously via a high-velocity jet, eliminating the need for traditional needles. This device is designed to penetrate the skin and administer medication or fluids into the subcutaneous tissue without direct needle insertion. Its mechanism relies on fluid propulsion rather than electrical components, ensuring a sterile and user-friendly injection process.

This system is intended for use in general hospital settings and has received FDA 510(k) clearance under the classification KZE. It is supplied as a single-use device, adhering to regulatory standards for fluid injectors. The device is regulated under FDA regulation 880.5430 and is classified as Class II. No specific MRI safety information or reusable components are indicated in the available data.

Other devices from Biovalve Technologies, Inc.

Questions

AI-generated answers, 1 Oct 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 Miniject Needle-Free Injection System FG-01-001 used for?

    The Miniject FG-01-001 is designed to administer medications or fluids subcutaneously without traditional needle insertion. It uses a high-velocity jet propulsion mechanism to penetrate the skin and deliver fluids into the subcutaneous tissue, making it ideal for general hospital use where sterile, user-friendly injections are required.

  • Is the Miniject FG-01-001 a single-use or reusable device?

    The Miniject FG-01-001 is supplied as a single-use device. This ensures sterility and compliance with regulatory standards for fluid injectors, reducing the risk of contamination or cross-infection between patients.

  • How is the Miniject FG-01-001 different from electrically powered injectors?

    Unlike electrically powered injectors, the Miniject FG-01-001 operates without electrical components. It relies solely on fluid propulsion to deliver the injection, simplifying its design and ensuring a more straightforward, non-electrical operation for healthcare providers.

  • What regulatory approval does the Miniject FG-01-001 hold?

    The Miniject FG-01-001 has received FDA 510(k) clearance under the classification KZE, indicating it is deemed substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under FDA regulation 880.5430.

  • Can the Miniject FG-01-001 be used in MRI environments?

    The available data does not specify any MRI safety information for the Miniject FG-01-001. Clinicians should verify compatibility with their specific MRI equipment and protocols before use in MRI environments.