510(k) · Cleared
ClearedNerivio
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 Feb 6, 2023 as substantially equivalent to K203181 (Theranica Bioelectronics, Ltd., 2021) after a 118-day review. Its family tree reaches back 3 generations to 2019. 3 later devices descend from it.
- Decided
- Feb 6, 2023
- Review
- 118 days
- Class
- Class II
- Product code
- QGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180059 (2019). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN180059 Nerivio MigraTheranica Bioelectronics, Ltd. · 2019
- 2 generations backK201824 NerivioTheranica Bio-Electronics, Ltd. · 2020
- 1 generation backK203181 Nerivio, FGD000075-4.7Theranica Bioelectronics, Ltd. · 2021
- This deviceK223169 NerivioTheranica Bioelectronics, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK232152 NerivioInfinityTheranica Bioelectronics, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241756 Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK250405 Nerivio; Nerivio InfinityTheranica Bio-Electronics, Ltd. · 2025 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180059 | Nerivio Migra | Theranica Bioelectronics, Ltd. | 2019 | — |
| −2 | K201824 | Nerivio | Theranica Bio-Electronics, Ltd. | 2020 | — |
| −1 | K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics, Ltd. | 2021 | — |
| 0 (this device) | K223169 | Nerivio | Theranica Bioelectronics, Ltd. | 2023 | — |
| +1 | K232152 | NerivioInfinity | Theranica Bioelectronics, Ltd. | 2023 | — |
| +1 | K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. | 2024 | — |
| +2 | K250405 | Nerivio; Nerivio Infinity | Theranica Bio-Electronics, Ltd. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K203181 | Nerivio, FGD000075-4.7Summary page 4…e: QGT Regulation Number: 21 CFR 882.5899 Predicate Device: Device name: Nerivio Manufacturer: Theranica Bio-Electronics LTD. 510(k) Number: K203181 Device Description: The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system de… | 2021 |
| † | K130987 | Valutrode Neurostimlation Electrodes | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232152 (Theranica Bioelectronics, Ltd., 2023) has gone furthest, with 2 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. 2023, 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 and/or preventive 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 for acute treatment, or every other day for preventive treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223169: Nerivio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223169
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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