510(k) · Cleared
ClearedDelphi Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantalx Neuroscience · GWF Stimulator, Electrical, Evoked Response
Cleared on Nov 5, 2024 as substantially equivalent to K160280 (Tonica Elektronik A/S, 2016) after a 90-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Nov 5, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K905059 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK905059 High Speed Magnetic StimulatorCadwell Laboratories, Inc. · 1991
- 3 generations backK051864 Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00The Magstim Company, Ltd. · 2005 · Recalled
- 2 generations backK061645 Magpro, Model R30Tonica Elektronik A/S · 2006
- 1 generation backK160280 MagPro R20Tonica Elektronik A/S · 2016
- This deviceK242345 Delphi StimulatorQuantalx Neuroscience · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905059 | High Speed Magnetic Stimulator | Cadwell Laboratories, Inc. | 1991 | — |
| −3 | K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00 | The Magstim Company, Ltd. | 2005 | 2 |
| −2 | K061645 | Magpro, Model R30 | Tonica Elektronik A/S | 2006 | — |
| −1 | K160280 | MagPro R20 | Tonica Elektronik A/S | 2016 | — |
| 0 (this device) | K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K160280 | MagPro R20Summary page 5…Review Panel: Neurology 3 PREDICATE DEVICE Primary Predicate: • MagPro, Model R20, by Tonica Elektronik A/S. Product code: GWF, cleared under: K160280. 4 DEVICE DESCRIPTION Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnost… | 2016 |
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 33 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242345: Delphi Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242345
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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