510(k) · Cleared
ClearedDerata Medi-Jector IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Derata Corp. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Feb 19, 1987 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Feb 19, 1987
- Review
- 92 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK864561 Derata Medi-Jector IVDerata Corp. · 1987
- Descendant · cites it directly · 9 of its ownK960285 Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug…Medi-Ject Corp. · 1996
- Descendant · cites it directly · 5 of its ownK962956 Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp. · 1996
- Descendant · 2 generations on · 3 of its ownK994384 ClickerBioject, Inc. · 2000
- Descendant · 3 generations on · 1 of its ownK050734 Cool.ClickBioject, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK991294 Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free…Medi-Ject Corp. · 1999
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K960285Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems…Medi-Ject Corp. · 1996 · cites it directly9descendants
- K962956Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp. · 1996 · cites it directly5descendants
- K994384ClickerBioject, Inc. · 2000 · 2 generations on3descendants
- K050734Cool.ClickBioject, Inc. · 2005 · 3 generations on1descendant
- K991294Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery…Medi-Ject Corp. · 1999 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | K962956 | Medi-Jector Choice Needle-Free Insulin Delivery System | Medi-Ject Corp. | 1996 | — |
| +2 | K994384 | Clicker | Bioject, Inc. | 2000 | — |
| +3 | K050734 | Cool.Click | Bioject, Inc. | 2005 | — |
| +2 | K991294 | Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin… | Medi-Ject Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
2 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?
- Of its descendants, K960285 (Medi-Ject Corp., 1996) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K864561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864561: Derata Medi-Jector IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864561
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026