510(k) · Cleared
Recalled · Class II · 2026Nerivio; Nerivio Infinity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theranica Bio-Electronics, Ltd. · QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Cleared on May 14, 2025 as substantially equivalent to K241756 (Theranica Bio-Electronics, Ltd., 2024) after a 90-day review. Its family tree reaches back 6 generations to 2019. It has been recalled once.
- Decided
- May 14, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- QGT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN180059 (2019). No later device cites it as a predicate yet.
- Root · 6 generations backDEN180059 Nerivio MigraTheranica Bioelectronics, Ltd. · 2019
- 5 generations backK201824 NerivioTheranica Bio-Electronics, Ltd. · 2020
- 4 generations backK203181 Nerivio, FGD000075-4.7Theranica Bioelectronics, Ltd. · 2021
- 3 generations backK223169 NerivioTheranica Bioelectronics, Ltd. · 2023
- 2 generations backK232152 NerivioInfinityTheranica Bioelectronics, Ltd. · 2023
- 1 generation backK241756 Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd. · 2024
- This deviceK250405 Nerivio; Nerivio InfinityTheranica Bio-Electronics, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN180059 | Nerivio Migra | Theranica Bioelectronics, Ltd. | 2019 | — |
| −5 | K201824 | Nerivio | Theranica Bio-Electronics, Ltd. | 2020 | — |
| −4 | K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics, Ltd. | 2021 | — |
| −3 | K223169 | Nerivio | Theranica Bioelectronics, Ltd. | 2023 | — |
| −2 | K232152 | NerivioInfinity | Theranica Bioelectronics, Ltd. | 2023 | — |
| −1 | K241756 | Nerivio; NerivioInfinity | Theranica Bio-Electronics, Ltd. | 2024 | — |
| 0 (this device) | K250405 | Nerivio; Nerivio Infinity | Theranica Bio-Electronics, Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K241756 | Nerivio; NerivioInfinitySummary page 5…headache Regulation Number: 21 CFR 882.5899 Product Code: QGT Regulatory Class: Class II Predicate Device: Nerivio; NerivioInfinity, Theranica Bio-Electronics Ltd. (K241756) Predicate Device Regulation Number: 21 CFR 882.5899 Predicate Device Product Code: QGT Predicate Device Regulatory Class: Cla… | 2024 |
| † | K130987 | Valutrode Neurostimlation Electrodes | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2026 | Class II | Z-2855-2026 | Component design/selection | Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. |
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 11 months on median.
- None of the 6 ancestors has a recall.
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. 2025, 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?
Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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.
Nerivio Infinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 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/K250405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250405: Nerivio; Nerivio Infinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250405
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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