510(k) · Cleared
ClearedSAVI Dual (TM) Migraine Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eneura, Inc. · OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Cleared on May 16, 2023 as substantially equivalent to K182976 (Eneura®, Inc., 2019) after a 95-day review. Its family tree reaches back 4 generations to 2013.
- Decided
- May 16, 2023
- Review
- 95 days
- Class
- Class II
- Product code
- OKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN130022 (2013). No later device cites it as a predicate yet.
- Root · 4 generations backDEN130022 Neuralieve Cerena Transcranial Magnetic StimulatorEneura Therapeutics · 2013
- 3 generations backK140094 Springtms Total Migraine SystemEneura Therapeutics, LLC · 2014
- 2 generations backK162797 SpringTMSEneura, Inc. · 2017
- 1 generation backK182976 SpringTMSEneura®, Inc. · 2019
- This deviceK230358 SAVI Dual (TM) Migraine TherapyEneura, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130022 | Neuralieve Cerena Transcranial Magnetic Stimulator | Eneura Therapeutics | 2013 | — |
| −3 | K140094 | Springtms Total Migraine System | Eneura Therapeutics, LLC | 2014 | — |
| −2 | K162797 | SpringTMS | Eneura, Inc. | 2017 | — |
| −1 | K182976 | SpringTMS | Eneura®, Inc. | 2019 | — |
| 0 (this device) | K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023 | — |
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 OKP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OKP devicesOKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OKP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OKP
Too few OKP 510(k)s in any year since 2007 to give a median.
Recalls per year · OKP
No recall names OKP since 2007.
Adverse event reports per year · OKP
1in 2024
MAUDE reports naming product code OKP, 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 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SAVI Dual™ Migraine Therapy device is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230358: SAVI Dual (TM) Migraine Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230358
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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