# K022502: Injex 30 Needle Free Injection System, Model 100000

- Pathway: 510(k) (Traditional)
- Applicant: Equidyne Systems, Inc.
- Decided: Sep 5, 2002 after 38 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: 4 generations back to K864561 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991294: Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery System, Medi-Ject Corp. (1999) Summary page 1.

## Indications for use
The over the counter Injex 30 Needle-Free Insulin Injection System is intended for the subcutaneous injection of U-100 insulin. The Ampule is labeled as suitable for administration of 5 to 30 insulin units in 1 unit increments.

Source page: https://510kreport.com/device/K022502
Methodology: https://510kreport.com/methodology