510(k) · Cleared
ClearedPersonal Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Union Medico Aps · KZH Introducer, Syringe Needle
Cleared on Feb 16, 2005 as substantially equivalent to K993385 (Owen Mumford USA, Inc., 1999) and 1 other predicate after a 449-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 449 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945660 (1995). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945660 Autoject 2Owen Mumford USA, Inc. · 1995 · Recalled
- 1 generation backK013362 Autoject 2Owen Mumford USA, Inc. · 2001
- This deviceK033696 Personal InjectorUnion Medico Aps · 2005
- Descendant · cites it directly · 2 of its ownK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- Descendant · 2 generations on · 0 of its ownK243232 GripMateSynthon Hispania S.L. · 2024
- Descendant · 2 generations on · 0 of its ownK141384 Whisperject AutoinjectorScandinavian Health Limited · 2014
- Descendant · cites it directly · 0 of its ownK060389 Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K124026Lobster Auto-InjectorScandinavian Health Limited · 2013 · cites it directly2descendants
- K243232GripMateSynthon Hispania S.L. · 2024 · 2 generations on0descendants
- K141384Whisperject AutoinjectorScandinavian Health Limited · 2014 · 2 generations on0descendants
- K060389Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | 3 |
| −1 | K013362 | Autoject 2 | Owen Mumford USA, Inc. | 2001 | — |
| 0 (this device) | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| +1 | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| +2 | K243232 | GripMate | Synthon Hispania S.L. | 2024 | — |
| +2 | K141384 | Whisperject Autoinjector | Scandinavian Health Limited | 2014 | — |
| +1 | K060389 | Confidose IM Auto-Injector | Pharma-Pen, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 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 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 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin 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.
What descends from it? (4)
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K124026 (Scandinavian Health Limited, 2013) has gone furthest, with 2 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 | — |
What is it indicated for?
Personal Injector is intended for use by patients to self-administer or by care-givers for injection of FDA approved drugs or biologics. Personal Injector is intended to introduce the needle below the skin surface.
Personal Injector is designed to accommodate two different and replaceable syringe-holders. Personal Injector is intended for the use with FDA approved fixed or non-fixed needle syringes supplied with specific injection regimens.
Personal Injector is intended to be used in any setting including the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033696 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033696: Personal Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033696
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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