De Novo · Granted
GrantedDelphi-MD System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantalx Neuroscience, Ltd. · SFN Non-Invasive Evoked Response Brain Stimulator
Granted on Aug 20, 2025 as a new device type through De Novo after a 229-day review.
- Decided
- Aug 20, 2025
- Review
- 229 days
- Class
- Class II
- Product code
- SFN
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SFN devicesSFN Non-Invasive Evoked Response Brain Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFN
Too few SFN 510(k)s in any year since 2007 to give a median.
Recalls per year · SFN
No recall names SFN since 2007.
Adverse event reports per year · SFN
No MAUDE report names SFN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Delphi-MD System is intended to elicit, amplify, record, and display brain evoked potentials to transcranial magnetic stimulation (TEPs) of the left and right primary motor cortex, dorsolateral prefrontal cortex, and primary visual cortex. The device is also intended to analyze TEPs and provide quantitative output parameters of the evoked response including the TEP waveform, global mean field potential, local mean field potential distribution maps…
Read the full statement (112 words)
The Delphi-MD System is intended to elicit, amplify, record, and display brain evoked potentials to
transcranial magnetic stimulation (TEPs) of the left and right primary motor cortex, dorsolateral
prefrontal cortex, and primary visual cortex. The device is also intended to analyze TEPs and provide
quantitative output parameters of the evoked response including the TEP waveform, global mean
field potential, local mean field potential distribution maps, quantify amplitudes and latencies of the
response, and present the output parameters compared to a normative reference database. The
normative reference database age range is limited to 50-75 years of age.
The Delphi-MD System is not to be relied on solely to make or confirm a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250002 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250002: Delphi-MD System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250002
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026