# DEN180041: Monarch eTNS System

- Pathway: De Novo (Direct)
- Applicant: Neurosigma, Inc.
- Decided: Apr 19, 2019 after 263 days
- Product code: QGL (Transcutaneous Nerve Stimulator For Adhd)
- Device class: 2
- Regulation: 21 CFR 882.5898
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K213629: SMILE (2023), 1 descendant of its own
- K243289: Addnox (BPSPM1) (2025), 0 descendants of its own
- K232991: BT-1000 (2024), 0 descendants of its own
- K233293: Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN180041
Methodology: https://510kreport.com/methodology