510(k) · Cleared
ClearedNerivio, FGD000075-4.7
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
Cleared on Jan 22, 2021 as substantially equivalent to K201824 (Theranica Bio-Electronics, Ltd., 2020) after an 88-day review. Its family tree reaches back 2 generations to 2019. 4 later devices descend from it.
- Decided
- Jan 22, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- QGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180059 (2019). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN180059 Nerivio MigraTheranica Bioelectronics, Ltd. · 2019
- 1 generation backK201824 NerivioTheranica Bio-Electronics, Ltd. · 2020
- This deviceK203181 Nerivio, FGD000075-4.7Theranica Bioelectronics, Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK223169 NerivioTheranica Bioelectronics, Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK232152 NerivioInfinityTheranica Bioelectronics, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK241756 Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK250405 Nerivio; Nerivio InfinityTheranica Bio-Electronics, Ltd. · 2025 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K223169NerivioTheranica Bioelectronics, Ltd. · 2023 · cites it directly3descendants
- K232152NerivioInfinityTheranica Bioelectronics, Ltd. · 2023 · 2 generations on2descendants
- K241756Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd. · 2024 · 2 generations on1descendant
- K250405Nerivio; Nerivio InfinityTheranica Bio-Electronics, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180059 | Nerivio Migra | Theranica Bioelectronics, Ltd. | 2019 | — |
| −1 | K201824 | Nerivio | Theranica Bio-Electronics, Ltd. | 2020 | — |
| 0 (this device) | K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics, Ltd. | 2021 | — |
| +1 | K223169 | Nerivio | Theranica Bioelectronics, Ltd. | 2023 | — |
| +2 | K232152 | NerivioInfinity | Theranica Bioelectronics, Ltd. | 2023 | — |
| +2 | K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. | 2024 | — |
| +3 | K250405 | Nerivio; Nerivio Infinity | Theranica Bio-Electronics, Ltd. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 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 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
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 |
|---|---|---|---|
| * | K201824 | NerivioSummary page 4…tory Class: Class II Product Code: QGT Predicate Device: Device name: Nerivio Manufacturer: Theranica Bio-Electronics LTD. 510(K) Number: K201824 Device Description: The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system de… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223169 | Nerivio | 2023 | 3 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223169 (Theranica Bioelectronics, Ltd., 2023) has gone furthest, with 3 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. 2021, 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 is indicated for acute treatment of migraine with or without aura in patients 12 years of age or older.
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/K203181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203181: Nerivio, FGD000075-4.7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203181
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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