510(k) · Cleared
ClearedSHL Disposable Autoinjector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shl Medical, USA · KZH Introducer, Syringe Needle
Cleared on Jun 24, 2005 as substantially equivalent to K000482 (Owen Mumford, Ltd., 2000) after a 122-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Jun 24, 2005
- Review
- 122 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000482 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000482 Modification to Autoject MiniOwen Mumford, Ltd. · 2000
- This deviceK050434 SHL Disposable AutoinjectorShl Medical, USA · 2005
- Descendant · cites it directly · 3 of its ownK060141 DAI-RShl Medical, USA · 2006
- Descendant · 2 generations on · 2 of its ownK070100 Haselmeier PenHaselmeier Sarl · 2007
- Descendant · 3 generations on · 0 of its ownK083457 TactipenHaselmeier GmbH · 2009
- Descendant · 3 generations on · 0 of its ownK082616 Haselmeier Pen 8Haselmeier GmbH · 2008
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000482 | Modification to Autoject Mini | Owen Mumford, Ltd. | 2000 | — |
| 0 (this device) | K050434 | SHL Disposable Autoinjector | Shl Medical, USA | 2005 | — |
| +1 | K060141 | DAI-R | Shl Medical, USA | 2006 | — |
| +2 | K070100 | Haselmeier Pen | Haselmeier Sarl | 2007 | — |
| +3 | K083457 | Tactipen | Haselmeier GmbH | 2009 | — |
| +3 | K082616 | Haselmeier Pen 8 | Haselmeier GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K000482 | Modification to Autoject MiniSummary page 1…on Name: Introducer, Syringe Needle 3. Device to which substantial equivalence is claimed Device Name: Owen Mumford Autoject Mini 510(k) Clearance Number: K000482 Device Common Name: Syringe needle introducer Classification Name: Introducer, Syringe Needle 4. Device Descriptio… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060141 | DAI-R | 2006 | 3 |
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?
DAITM is a hand-held mechanical device intended for the automated, subcutaneous, self-administration of FDA-approved drugs and biologics. DAITM is designed to be used with the standard 1.OmL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAITM is for use in the home environment to aid and support prescribed treatment and therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050434: SHL Disposable Autoinjector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050434
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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