510(k) · Cleared
ClearedLobster Auto-Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scandinavian Health Limited · KZH Introducer, Syringe Needle
Cleared on Sep 13, 2013 as substantially equivalent to K945660 (Owen Mumford USA, Inc., 1995) and 2 other predicates after a 259-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 13, 2013
- Review
- 259 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945660 (1995). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945660 Autoject 2Owen Mumford USA, Inc. · 1995 · Recalled
- 2 generations backK013362 Autoject 2Owen Mumford USA, Inc. · 2001
- 1 generation backK033696 Personal InjectorUnion Medico Aps · 2005
- This deviceK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- Descendant · cites it directly · 0 of its ownK243232 GripMateSynthon Hispania S.L. · 2024
- Descendant · cites it directly · 0 of its ownK141384 Whisperject AutoinjectorScandinavian Health Limited · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | 3 |
| −2 | K013362 | Autoject 2 | Owen Mumford USA, Inc. | 2001 | — |
| −1 | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| 0 (this device) | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| +1 | K243232 | GripMate | Synthon Hispania S.L. | 2024 | — |
| +1 | K141384 | Whisperject Autoinjector | Scandinavian Health Limited | 2014 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K945660 | Autoject 2Summary page 1…Class 11 Product Code: KZH 5.3 Predicate Devices: Device name: A utojeci 2 510(k) number: K945660 Device name: A uloject 2 510(k) number: K013362 Device name: Personal Injec… | 1995 |
| * | K013362 | Autoject 2Summary page 1…te Devices: Device name: A utojeci 2 510(k) number: K945660 Device name: A uloject 2 510(k) number: K013362 Device name: Personal Injector",t 510(k) number: K033696… | 2001 |
| * | K033696 | Personal InjectorSummary page 1…60 Device name: A uloject 2 510(k) number: K013362 Device name: Personal Injector",t 510(k) number: K033696 Page I of 3 SHL GROUP 5.4 Substantial Equivalence… | 2005 |
What descends from it? (2)
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 18 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243232 (Synthon Hispania S.L., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K945660.
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Lobster device is intended for use with a 1 mL glass syringe, containing a fixed needle of 27 to 29 gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124026: Lobster Auto-Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124026
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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