# K050734: Cool.Click

- Pathway: 510(k) (Traditional)
- Applicant: Bioject, Inc.
- Decided: Jun 3, 2005 after 74 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994384: Clicker, Bioject, Inc. (2000) Summary page 1.

## Most influential descendants
- K060819: Cool.Click 2 (2006), 0 descendants of its own

## Indications for use
This product is indicated for Needle-Free Self Injection of Saizen® [somatotropin (rDNA origin) for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

Source page: https://510kreport.com/device/K050734
Methodology: https://510kreport.com/methodology