# K962956: Medi-Jector Choice Needle-Free Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Ject Corp.
- Decided: Oct 7, 1996 after 69 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 K864561 (1987). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864561: Derata Medi-Jector IV, Derata Corp. (1987) Summary page 1.
- K883847: Derata Medi-Jector V, Derata Corp. (1988) Summary page 1.
- K960285: Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific, Medi-Ject Corp. (1996) Summary page 1.

## Most influential descendants
- K991294: Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery System (1999), 1 descendant of its own
- K090959: Lectrajet Needle-Free Injection System, Model: M3 RA (2009), 0 descendants of its own
- K024018: Avant Guardian 101 (2003), 0 descendants of its own
- K020786: Injex Needle-Free Injection System; Rojex Needle-Free Injection System (2002), 0 descendants of its own
- K022502: Injex 30 Needle Free Injection System, Model 100000 (2002), 0 descendants of its own

## Indications for use
The Medi-Jector Choice Needle-Fee Insulin Delivery System is intended for the subcutaneous injection of U-100 insulin.

Source page: https://510kreport.com/device/K962956
Methodology: https://510kreport.com/methodology