510(k) · Cleared
Recalled · Class II · 2019Autoject 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owen Mumford USA, Inc. · KZH Introducer, Syringe Needle
Cleared on Aug 11, 1995 after a 267-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 11, 1995
- Review
- 267 days
- Class
- Class II
- Product code
- KZH
- Recalls
- 3
- Predicates
- 0
13 later devices descend from it, 5 citing it directly.
- This deviceK945660 Autoject 2Owen Mumford USA, Inc. · 1995
- Descendant · cites it directly · 9 of its ownK013362 Autoject 2Owen Mumford USA, Inc. · 2001
- Descendant · 2 generations on · 4 of its ownK033696 Personal InjectorUnion Medico Aps · 2005
- Descendant · cites it directly · 2 of its ownK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- Descendant · 2 generations on · 2 of its ownK032425 Invisiject Resusable Auto-InjectorBiogen · 2003
- Descendant · cites it directly · 1 of its ownK042557 Innoject Auto-InjectorInnoject, Inc. · 2004
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K013362Autoject 2Owen Mumford USA, Inc. · 2001 · cites it directly9descendants
- K033696Personal InjectorUnion Medico Aps · 2005 · 2 generations on4descendants
- K124026Lobster Auto-InjectorScandinavian Health Limited · 2013 · cites it directly2descendants
- K032425Invisiject Resusable Auto-InjectorBiogen · 2003 · 2 generations on2descendants
- K042557Innoject Auto-InjectorInnoject, Inc. · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | — |
| +1 | K013362 | Autoject 2 | Owen Mumford USA, Inc. | 2001 | — |
| +2 | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| +1 | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| +2 | K032425 | Invisiject Resusable Auto-Injector | Biogen | 2003 | — |
| +1 | K042557 | Innoject Auto-Injector | Innoject, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 135 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2019 | Class II | Z-0264-2020 | Employee error | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107 |
| Jul 17, 2019 | Class II | Z-0263-2020 | Employee error | There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107 |
| Nov 24, 2014 | Class II | Z-1366-2015 | Process control | The syringe carrier is missing components: a damper and spring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013362 (Owen Mumford USA, Inc., 2001) has gone furthest, with 9 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/K945660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945660: Autoject 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945660
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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