510(k) · Cleared
ClearedSpringtms Total Migraine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eneura Therapeutics, LLC · OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Cleared on May 21, 2014 as substantially equivalent to DEN130022 (Eneura Therapeutics, 2013) after a 127-day review. Its family tree reaches back 1 generation to 2013. 4 later devices descend from it.
- Decided
- May 21, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- OKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130022 (2013). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130022 Neuralieve Cerena Transcranial Magnetic StimulatorEneura Therapeutics · 2013
- This deviceK140094 Springtms Total Migraine SystemEneura Therapeutics, LLC · 2014
- Descendant · cites it directly · 2 of its ownK162797 SpringTMSEneura, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK182976 SpringTMSEneura®, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK230358 SAVI Dual (TM) Migraine TherapyEneura, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK161663 sTMS miniEneura, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130022 | Neuralieve Cerena Transcranial Magnetic Stimulator | Eneura Therapeutics | 2013 | — |
| 0 (this device) | K140094 | Springtms Total Migraine System | Eneura Therapeutics, LLC | 2014 | — |
| +1 | K162797 | SpringTMS | Eneura, Inc. | 2017 | — |
| +2 | K182976 | SpringTMS | Eneura®, Inc. | 2019 | — |
| +3 | K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023 | — |
| +1 | K161663 | sTMS mini | Eneura, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 OKP? 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 OKP device
- #1 K230358 SAVI Dual (TM) Migraine Therapyscore 6.2 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | DEN130022 | Neuralieve Cerena Transcranial Magnetic Stimulator Our reading of the summary gave K130556, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130022, Neuralieve Cerena Transcranial Magnetic Stimulator (Eneura Therapeutics), granted Dec 13, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K162797 (Eneura, Inc., 2017) has gone furthest, with 2 descendants of its own.
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. 2014, 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 eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140094: Springtms Total Migraine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140094
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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