510(k) · Cleared
ClearedAddnox (BPSPM1)
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 Jan 16, 2025 as substantially equivalent to K213629 (Nu Eyne Co., Ltd., 2023) after a 90-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Jan 16, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- QGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180041 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K232991 BT-1000score 7.9 · 1 generation · 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 |
|---|---|---|---|
| * | K213629 | SMILESummary page 6…Predicate Device Manufacturer Nu Eyne Co., Ltd. Device Name (Trade Name) SMILE 510(k) Number K213629 Transcutaneous electrical nerve stimulator for Attention Regulation Name… | 2023 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
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. 2025, 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 ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243289: Addnox (BPSPM1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243289
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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