# K960285: Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Ject Corp.
- Decided: Apr 17, 1996 after 89 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: 1 generation back to K864561 (1987). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 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.
- K920631: Bioject Jet Injection System, Bioject, Inc. (1994) Summary page 1.

## Most influential descendants
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System (1996), 5 descendants of its own
- K994384: Clicker (2000), 3 descendants of its own
- K050734: Cool.Click (2005), 1 descendant of its own
- 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

## Indications for use
The device is intended only for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. It is intended for the subcutaneous administration of the reconstituted drug by high-pressure injection either by health care practitioners or directly by patients.

Source page: https://510kreport.com/device/K960285
Methodology: https://510kreport.com/methodology