510(k) · Cleared
ClearedGripMate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthon Hispania S.L. · KZH Introducer, Syringe Needle
Cleared on Dec 2, 2024 as substantially equivalent to K124026 (Scandinavian Health Limited, 2013) after a 54-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 2, 2024
- Review
- 54 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945660 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945660 Autoject 2Owen Mumford USA, Inc. · 1995 · Recalled
- 3 generations backK013362 Autoject 2Owen Mumford USA, Inc. · 2001
- 2 generations backK033696 Personal InjectorUnion Medico Aps · 2005
- 1 generation backK124026 Lobster Auto-InjectorScandinavian Health Limited · 2013
- This deviceK243232 GripMateSynthon Hispania S.L. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | 3 |
| −3 | K013362 | Autoject 2 | Owen Mumford USA, Inc. | 2001 | — |
| −2 | K033696 | Personal Injector | Union Medico Aps | 2005 | — |
| −1 | K124026 | Lobster Auto-Injector | Scandinavian Health Limited | 2013 | — |
| 0 (this device) | K243232 | GripMate | Synthon Hispania S.L. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 K213429 AccuSert Needle Inserterscore 4.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K124026 | Lobster Auto-InjectorSummary page 5…name: Introducer, Syringe Needle Regulation number: 880.6920 Product codes(s): KZH LEGALLY MARKETED PREDICATE DEVICES Device name: Lobster Auto- Injector 510(k) number: K124026 Product codes(s): KZH Page 1 of 6 DEVICE DESCRIPTION SUMMAR… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K124026.
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½” fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243232: GripMate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243232
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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