510(k) · Cleared
ClearedClicker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioject, Inc. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Jun 22, 2000 as substantially equivalent to K960285 (Medi-Ject Corp., 1996) and 1 other predicate after a 177-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Jun 22, 2000
- Review
- 177 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864561 (1987). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK864561 Derata Medi-Jector IVDerata Corp. · 1987
- 1 generation backK960285 Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug…Medi-Ject Corp. · 1996
- This deviceK994384 ClickerBioject, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK050734 Cool.ClickBioject, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK060819 Cool.Click 2Medical House Products Limited · 2006
- Descendant · cites it directly · 0 of its ownK024018 Avant Guardian 101Avant Medical Corporation · 2003
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864561 | Derata Medi-Jector IV | Derata Corp. | 1987 | — |
| −1 | K960285 | Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery… | Medi-Ject Corp. | 1996 | — |
| 0 (this device) | K994384 | Clicker | Bioject, Inc. | 2000 | — |
| +1 | K050734 | Cool.Click | Bioject, Inc. | 2005 | — |
| +1 | K060819 | Cool.Click 2 | Medical House Products Limited | 2006 | — |
| +1 | K024018 | Avant Guardian 101 | Avant Medical Corporation | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K960285 | Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems…Summary page 1…17, 1999 Clicker™ Needle Free Injector, Jet Injector Jet Injector, Non-Electrically Powered Fluid Injector e Medi-Jector Needle-Free Bio-Tropin™ Drug Delivery System K960285 e Vitajet K962625 Clicker™ Needle-Free Self-Injection - Device for Personal Use with Saizen® [somatropin (rDNA origin) for inj… | 1996 |
| * | K962625 | VitajetSummary page 1…Needle Free Injector, Jet Injector Jet Injector, Non-Electrically Powered Fluid Injector e Medi-Jector Needle-Free Bio-Tropin™ Drug Delivery System K960285 e Vitajet K962625 Clicker™ Needle-Free Self-Injection - Device for Personal Use with Saizen® [somatropin (rDNA origin) for injection]. Needle Fr… | 1996 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K050734 (Bioject, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K960285.
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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994384: Clicker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994384
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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