# K060819: Cool.Click 2

- Pathway: 510(k) (Traditional)
- Applicant: Medical House Products Limited
- Decided: Jun 16, 2006 after 81 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: 4 generations back to K864561 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050734: Cool.Click, Bioject, Inc. (2005) Summary page 1.
- K003908: Serojet, Bioject, Inc. (2001) Summary page 1.
- K994384: Clicker, Bioject, Inc. (2000) Summary page 1.
- K010623: Reconstitution Kit & Vial Connector, Bioject, Inc. (2001) Summary page 1.

## Indications for use
The cool.click 2TM Needle-free Growth Hormone Delivery System is indicated for the administration of Serono's growth hormone drug products and is intended for home use by patients authorized by their physicians to self-inject.

Source page: https://510kreport.com/device/K060819
Methodology: https://510kreport.com/methodology