510(k) · Cleared
ClearedAutojet 2 (Non-Fixed Needle Type)
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 10, 1999 after a 33-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 33 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK993385 Autojet 2 (Non-Fixed Needle Type)Owen Mumford USA, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK033696 Personal InjectorUnion Medico Aps · 2005
- Descendant · 2 generations on · 2 of its ownK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- Descendant · 3 generations on · 0 of its ownK243232 GripMateSynthon Hispania S.L. · 2024
- Descendant · 3 generations on · 0 of its ownK141384 Whisperject AutoinjectorScandinavian Health Limited · 2014
- Descendant · 2 generations on · 0 of its ownK060389 Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K033696Personal InjectorUnion Medico Aps · 2005 · cites it directly4descendants
- K124026Lobster Auto-InjectorScandinavian Health Limited · 2013 · 2 generations on2descendants
- K243232GripMateSynthon Hispania S.L. · 2024 · 3 generations on0descendants
- K141384Whisperject AutoinjectorScandinavian Health Limited · 2014 · 3 generations on0descendants
- K060389Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993385 | Autojet 2 (Non-Fixed Needle Type) | Owen Mumford USA, Inc. | 1999 | — |
| +1 | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| +2 | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| +3 | K243232 | GripMate | Synthon Hispania S.L. | 2024 | — |
| +3 | K141384 | Whisperject Autoinjector | Scandinavian Health Limited | 2014 | — |
| +2 | K060389 | Confidose IM Auto-Injector | Pharma-Pen, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 9.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Autoject® 2 (Fixed Needle type) Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033696 | Personal Injector | 2005 | 4 |
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, K033696 (Union Medico Aps, 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 | — |
What is it indicated for?
A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable 1ml non-fixed needle syringe and to accommodate self use in the horne by the patient in order to aid and support compliance with the 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/K993385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993385: Autojet 2 (Non-Fixed Needle Type).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993385
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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