510(k) · Cleared
ClearedAutoject 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 Nov 13, 2001 as substantially equivalent to K945660 (Owen Mumford USA, Inc., 1995) after a 34-day review. Its family tree reaches back 1 generation to 1995. 9 later devices descend from it.
- Decided
- Nov 13, 2001
- Review
- 34 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945660 (1995). 9 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK945660 Autoject 2Owen Mumford USA, Inc. · 1995 · Recalled
- This deviceK013362 Autoject 2Owen Mumford USA, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK033696 Personal InjectorUnion Medico Aps · 2005
- Descendant · cites it directly · 2 of its ownK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- Descendant · cites it directly · 2 of its ownK032425 Invisiject Resusable Auto-InjectorBiogen · 2003
- Descendant · 2 generations on · 0 of its ownK243232 GripMateSynthon Hispania S.L. · 2024
- Descendant · cites it directly · 0 of its ownK141384 Whisperject AutoinjectorScandinavian Health Limited · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K033696Personal InjectorUnion Medico Aps · 2005 · cites it directly4descendants
- K124026Lobster Auto-InjectorScandinavian Health Limited · 2013 · cites it directly2descendants
- K032425Invisiject Resusable Auto-InjectorBiogen · 2003 · cites it directly2descendants
- K243232GripMateSynthon Hispania S.L. · 2024 · 2 generations on0descendants
- K141384Whisperject AutoinjectorScandinavian Health Limited · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | 3 |
| 0 (this device) | K013362 | Autoject 2 | Owen Mumford USA, Inc. | 2001 | — |
| +1 | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| +1 | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| +1 | K032425 | Invisiject Resusable Auto-Injector | Biogen | 2003 | — |
| +2 | K243232 | GripMate | Synthon Hispania S.L. | 2024 | — |
| +1 | K141384 | Whisperject Autoinjector | Scandinavian Health Limited | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 2 | 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 9.3 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945660 | Autoject 2Summary page 1…rietta. Georgia 30062. USA. Tel: 770 977-2226. Fax: 770-977-2866 Device Name: Autoject 2. Classification Name: Syringe Needle Introducers Predicate Device: Autoject 2 (K945660) Owen Mumford Limited has been successfully marketing syringe needle introducers throughout the world since 1986. These product… | 1995 |
| Kept off the family tree | K945567 | FDA’s K945567 is QC CAP Our OCR of the scanned summary read K945567, FDA’s number for QC CAP (Medionics International, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Autoject 2”. Kept off the family tree. Summary page 1…T.C application are such that it makes the principle safe and effective and user friendly in its function and is simply a later model of the current approved Autoject 2 (K945567). 510(K) Submission. Autoject 2. September 2001 Page 19 K6133L2 Yasel—éf z Performance. A number of tests hav… | 1995 |
What descends from it? (9)
6 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?
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?
The Autoject 2 is a hand held mechanical device intended for a self-administered automated
subcutaneous injection of FDA approved drugs.
The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the
patient or care-giver to aid and support a recommended treatment regime.
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/K013362 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013362: Autoject 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013362
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026