510(k) · Cleared
ClearedSMILE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Eyne Co., Ltd. · QGL Transcutaneous Nerve Stimulator For Adhd
Cleared on Feb 12, 2023 as substantially equivalent to DEN180041 (Neurosigma, Inc., 2019) after a 452-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it.
- Decided
- Feb 12, 2023
- Review
- 452 days
- Class
- Class II
- Product code
- QGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180041 (2019). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243289Addnox (BPSPM1)Nu Eyne Co., Ltd. · 2025 · cites it directly0descendants
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) | K213629 | SMILE | Nu Eyne Co., Ltd. | 2023 | — |
| +1 | K243289 | Addnox (BPSPM1) | Nu Eyne Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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…Predicate Device Manufacturer NeuroSigma, Inc. Device Name (Trade Name) Monarch eTNS System De Novo Number DEN180041 Page 1 4. SUBJECT DEVICE DESCRIPTION Transcutaneous electrica… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243289 | Addnox (BPSPM1) | 2025 | 0 |
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?
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. 2023, 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 SMILE 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 to be 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/K213629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213629: SMILE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213629
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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