De Novo · Granted
GrantedNerivio Migra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theranica Bioelectronics, Ltd. · QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Granted on May 20, 2019 as a new device type through De Novo after a 195-day review. 6 later devices descend from it.
- Decided
- May 20, 2019
- Review
- 195 days
- Class
- Class II
- Product code
- QGT
- Recalls
- None
6 later devices descend from it, 1 citing it directly.
- This deviceDEN180059 Nerivio MigraTheranica Bioelectronics, Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK201824 NerivioTheranica Bio-Electronics, Ltd. · 2020
- Descendant · 2 generations on · 4 of its ownK203181 Nerivio, FGD000075-4.7Theranica Bioelectronics, Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK223169 NerivioTheranica Bioelectronics, Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK232152 NerivioInfinityTheranica Bioelectronics, Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK241756 Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201824NerivioTheranica Bio-Electronics, Ltd. · 2020 · cites it directly5descendants
- K203181Nerivio, FGD000075-4.7Theranica Bioelectronics, Ltd. · 2021 · 2 generations on4descendants
- K223169NerivioTheranica Bioelectronics, Ltd. · 2023 · 3 generations on3descendants
- K232152NerivioInfinityTheranica Bioelectronics, Ltd. · 2023 · 4 generations on2descendants
- K241756Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180059 | Nerivio Migra | Theranica Bioelectronics, Ltd. | 2019 | — |
| +1 | K201824 | Nerivio | Theranica Bio-Electronics, Ltd. | 2020 | — |
| +2 | K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics, Ltd. | 2021 | — |
| +3 | K223169 | Nerivio | Theranica Bioelectronics, Ltd. | 2023 | — |
| +4 | K232152 | NerivioInfinity | Theranica Bioelectronics, Ltd. | 2023 | — |
| +4 | K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 QGT? 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 QGT device
- #1 K241756 Nerivio; NerivioInfinityscore 12.3 · 5 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201824 | Nerivio | 2020 | 5 |
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, K201824 (Theranica Bio-Electronics, Ltd., 2020) has gone furthest, with 5 descendants of its own.
How does its category compare?
All QGT devicesQGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QGT
Too few QGT 510(k)s in any year since 2007 to give a median.
Recalls per year · QGT
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QGT
3in 2022
MAUDE reports naming product code QGT, 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 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Nerivio Migra is indicated for acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180059 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180059: Nerivio Migra.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180059
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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