# K032976: Biovalve Miniject Needle-Free Injection System, Model FG-01-001

- Pathway: 510(k) (Traditional)
- Applicant: Biovalve Technologies, Inc.
- Decided: Apr 16, 2004 after 205 days
- Product code: KZE (Injector, Fluid, Non-Electrically Powered)
- Device class: 2
- Regulation: 21 CFR 880.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920631 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960373: Biojector 2000 Model 1B02000, Bioject, Inc. (1997) Summary page 1.
- K920631: Bioject Jet Injection System, Bioject, Inc. (1994) Summary page 1.

## Indications for use
The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non-electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physician to self inject medication.

Source page: https://510kreport.com/device/K032976
Methodology: https://510kreport.com/methodology