510(k) · Cleared
ClearedModification to Autoject Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owen Mumford, Ltd. · KZH Introducer, Syringe Needle
Cleared on Mar 6, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 6, 2000
- Review
- 21 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK000482 Modification to Autoject MiniOwen Mumford, Ltd. · 2000
- Descendant · cites it directly · 4 of its ownK050434 SHL Disposable AutoinjectorShl Medical, USA · 2005
- Descendant · 2 generations on · 3 of its ownK060141 DAI-RShl Medical, USA · 2006
- Descendant · 3 generations on · 2 of its ownK070100 Haselmeier PenHaselmeier Sarl · 2007
- Descendant · cites it directly · 1 of its ownK073476 Compact Auto-Safety Injector (Casi)Medical House (Asi) Limited · 2008
- Descendant · 4 generations on · 0 of its ownK083457 TactipenHaselmeier GmbH · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K050434SHL Disposable AutoinjectorShl Medical, USA · 2005 · cites it directly4descendants
- K060141DAI-RShl Medical, USA · 2006 · 2 generations on3descendants
- K070100Haselmeier PenHaselmeier Sarl · 2007 · 3 generations on2descendants
- K073476Compact Auto-Safety Injector (Casi)Medical House (Asi) Limited · 2008 · cites it directly1descendant
- K083457TactipenHaselmeier GmbH · 2009 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000482 | Modification to Autoject Mini | Owen Mumford, Ltd. | 2000 | — |
| +1 | K050434 | SHL Disposable Autoinjector | Shl Medical, USA | 2005 | — |
| +2 | K060141 | DAI-R | Shl Medical, USA | 2006 | — |
| +3 | K070100 | Haselmeier Pen | Haselmeier Sarl | 2007 | — |
| +1 | K073476 | Compact Auto-Safety Injector (Casi) | Medical House (Asi) Limited | 2008 | — |
| +4 | K083457 | Tactipen | Haselmeier GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 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 KZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KZH device
- #1 K243232 GripMatescore 9.3 · 4 generations · no Class I recall
- #2 Held for the reportin 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? (7)
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, K050434 (Shl Medical, USA, 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KZH
Too few KZH 510(k)s in any year since 2007 to give a median.
Recalls per year · KZH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZH
16in 2025
MAUDE reports naming product code KZH, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 1 | 20 |
| 2012 | 2 | — | 0 | 20 |
| 2013 | 1 | — | 0 | 53 |
| 2014 | 1 | — | 0 | 138 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 68 |
| 2017 | 1 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 88 |
| 2019 | 0 | — | 2 | 95 |
| 2020 | 0 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 87 |
| 2022 | 1 | — | 0 | 58 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000482: Modification to Autoject Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000482
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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