510(k) · Cleared
ClearedCool.Click 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical House Products Limited · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Jun 16, 2006 as substantially equivalent to K050734 (Bioject, Inc., 2005) and 3 other predicates after an 81-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jun 16, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K864561 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864561 Derata Medi-Jector IVDerata Corp. · 1987
- 3 generations backK960285 Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug…Medi-Ject Corp. · 1996
- 2 generations backK994384 ClickerBioject, Inc. · 2000
- 1 generation backK050734 Cool.ClickBioject, Inc. · 2005
- This deviceK060819 Cool.Click 2Medical House Products Limited · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864561 | Derata Medi-Jector IV | Derata Corp. | 1987 | — |
| −3 | K960285 | Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery… | Medi-Ject Corp. | 1996 | — |
| −2 | K994384 | Clicker | Bioject, Inc. | 2000 | — |
| −1 | K050734 | Cool.Click | Bioject, Inc. | 2005 | — |
| 0 (this device) | K060819 | Cool.Click 2 | Medical House Products Limited | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050734 | Cool.ClickSummary page 1…Needle-free Injector, Jet Injector Classification Name: Jet Injector, Non-Electrically Powered Fluid Injector Predicate Devices: cool.click K050734 Serojet K003908 Clicker K994384 Reconst… | 2005 |
| * | K003908 | SerojetSummary page 1…Classification Name: Jet Injector, Non-Electrically Powered Fluid Injector Predicate Devices: cool.click K050734 Serojet K003908 Clicker K994384 Reconstitution Kit & Vial Connector K0 10623… | 2001 |
| * | K994384 | ClickerSummary page 1…Electrically Powered Fluid Injector Predicate Devices: cool.click K050734 Serojet K003908 Clicker K994384 Reconstitution Kit & Vial Connector K0 10623 Device Description: cool.click 2TM is a nee… | 2000 |
| * | K010623 | Reconstitution Kit & Vial ConnectorSummary page 1…ick K050734 Serojet K003908 Clicker K994384 Reconstitution Kit & Vial Connector K0 10623 Device Description: cool.click 2TM is a needle-free delivery device for Serono growth ho… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KZE devicesKZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZE
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KZE
220in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KZE
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZE
1in 2025
MAUDE reports naming product code KZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 54 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 4 | 220 | 0 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060819: Cool.Click 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060819
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026