De Novo · Granted
GrantedMonarch 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
Granted on Apr 19, 2019 as a new device type through De Novo after a 263-day review. 4 later devices descend from it.
- Decided
- Apr 19, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- QGL
- Recalls
- None
4 later devices descend from it, 3 citing it directly.
- This deviceDEN180041 Monarch eTNS SystemNeurosigma, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK213629 SMILENu Eyne Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243289 Addnox (BPSPM1)Nu Eyne Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK232991 BT-1000Bistos Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233293 Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS)…Neurosigma, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K213629SMILENu Eyne Co., Ltd. · 2023 · cites it directly1descendant
- K243289Addnox (BPSPM1)Nu Eyne Co., Ltd. · 2025 · 2 generations on0descendants
- K232991BT-1000Bistos Co., Ltd. · 2024 · cites it directly0descendants
- K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®Neurosigma, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180041 | Monarch eTNS System | Neurosigma, Inc. | 2019 | — |
| +1 | K213629 | SMILE | Nu Eyne Co., Ltd. | 2023 | — |
| +2 | K243289 | Addnox (BPSPM1) | Nu Eyne Co., Ltd. | 2025 | — |
| +1 | K232991 | BT-1000 | Bistos Co., Ltd. | 2024 | — |
| +1 | K233293 | Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
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 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
3 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?
- Of its descendants, K213629 (Nu Eyne Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
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. 2019, 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 Monarch external Trigeminal Nerve Stimulation (eTNS) System 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/DEN180041 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180041: Monarch eTNS System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180041
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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