# K991294: Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery System

- Pathway: 510(k) (Special)
- Applicant: Medi-Ject Corp.
- Decided: Apr 23, 1999 after 8 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System, Medi-Ject Corp. (1996) Summary page 1.

## Most influential descendants
- K022502: Injex 30 Needle Free Injection System, Model 100000 (2002), 0 descendants of its own

## Indications for use
The over the counter Medi-Jector Choice Needle-Free Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin. The injector is labeled as suitable for administration of 2 to 50 insulin units in a 0.5 unit increment.

Source page: https://510kreport.com/device/K991294
Methodology: https://510kreport.com/methodology