# K994384: Clicker

- Pathway: 510(k) (Traditional)
- Applicant: Bioject, Inc.
- Decided: Jun 22, 2000 after 177 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). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K962625: Vitajet, Vitajet Corp. (1996) Summary page 1.

## Most influential descendants
- K050734: Cool.Click (2005), 1 descendant of its own
- K060819: Cool.Click 2 (2006), 0 descendants of its own
- K024018: Avant Guardian 101 (2003), 0 descendants of its own

## Indications for use
This product is indicated for use with Saizen® [somatropin (rDNAorigin) for injection] for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

Source page: https://510kreport.com/device/K994384
Methodology: https://510kreport.com/methodology