# K020786: Injex Needle-Free Injection System; Rojex Needle-Free Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Rosch AG Medizintechnic
- Decided: Sep 25, 2002 after 198 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: 3 generations back to K864561 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945873: Hypex (TM) Jet Injector, Equidyne Systems, Inc. (1995) Summary page 1.
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System, Medi-Ject Corp. (1996) Summary page 1.
- K003864: Injex 50 System, Equidyne Systems, Inc. (2001) Summary page 1.
- K003741: Jet Syringe Model-100500, Equidyne Systems, Inc. (2001)

## Indications for use
The INJEX TM- and ROJEX TM needle-free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.

Source page: https://510kreport.com/device/K020786
Methodology: https://510kreport.com/methodology