510(k) · Cleared
ClearedGeneration 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurosigma, Inc. · QGL Transcutaneous Nerve Stimulator For Adhd
Cleared on Jan 16, 2024 as substantially equivalent to DEN180041 (Neurosigma, Inc., 2019) after a 109-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jan 16, 2024
- Review
- 109 days
- Class
- Class II
- Product code
- QGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180041 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180041 Monarch eTNS SystemNeurosigma, Inc. · 2019
- This deviceK233293 Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS)…Neurosigma, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180041 | Monarch eTNS System | Neurosigma, Inc. | 2019 | — |
| 0 (this device) | K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | 2024 | — |
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 QGL? 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 QGL device
- #1 K243289 Addnox (BPSPM1)score 9.0 · 2 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 |
|---|---|---|---|
| * | DEN180041 | Monarch eTNS SystemSummary page 4…Name: Monarch Gen 2 Classification Name: Transcutaneous Nerve Stimulator For ADHD, Neurology Regulatory Class: Class II Product Code: QGL Predicate Device DEN180041 - NeuroSigma, Inc., Monarch eTNS System Intended Use / Indications for Use The Generation 2.0 Monarch external Trigeminal Nerve… | 2019 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN180041.
How does its category compare?
All QGL devicesQGL Transcutaneous Nerve Stimulator For Adhd: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QGL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QGL
Too few QGL 510(k)s in any year since 2007 to give a median.
Recalls per year · QGL
No recall names QGL since 2007.
Adverse event reports per year · QGL
1in 2025
MAUDE reports naming product code QGL, 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 | 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (“Monarch Gen 2”) is indicated
for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through
12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by
prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K233293: Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233293
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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