510(k) · Cleared
ClearedDAI-R
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 12, 2006 as substantially equivalent to K050434 (Shl Medical, USA, 2005) after a 144-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 12, 2006
- Review
- 144 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000482 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000482 Modification to Autoject MiniOwen Mumford, Ltd. · 2000
- 1 generation backK050434 SHL Disposable AutoinjectorShl Medical, USA · 2005
- This deviceK060141 DAI-RShl Medical, USA · 2006
- Descendant · cites it directly · 2 of its ownK070100 Haselmeier PenHaselmeier Sarl · 2007
- Descendant · 2 generations on · 0 of its ownK083457 TactipenHaselmeier GmbH · 2009
- Descendant · 2 generations on · 0 of its ownK082616 Haselmeier Pen 8Haselmeier GmbH · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000482 | Modification to Autoject Mini | Owen Mumford, Ltd. | 2000 | — |
| −1 | K050434 | SHL Disposable Autoinjector | Shl Medical, USA | 2005 | — |
| 0 (this device) | K060141 | DAI-R | Shl Medical, USA | 2006 | — |
| +1 | K070100 | Haselmeier Pen | Haselmeier Sarl | 2007 | — |
| +2 | K083457 | Tactipen | Haselmeier GmbH | 2009 | — |
| +2 | K082616 | Haselmeier Pen 8 | Haselmeier GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050434 | SHL Disposable AutoinjectorSummary page 1…r 3. Device to which substantial equivalence is claimed Device Name: SHL Medical, USA Disposable Autoinjector "DAI" 510(k) Clearance Number: K050434 Device Common Name: Syringe needle introducer Classification Name: Syringe Needle Introducer 4. Devi… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070100 | Haselmeier Pen | 2007 | 2 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K070100 (Haselmeier Sarl, 2007) 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?
The DAI-RTM Autoinjector is a hand-held mechanical device intended for the automated, self-admihistration of FDA-approved drugs and biologics. The DAI-RTm Autoinjector is designed to be used with a standard Glass Barrel lmL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-RTM Autoinjector 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/K060141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060141: DAI-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060141
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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