510(k) · Cleared
ClearedSpringTMS
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 Jun 26, 2017 as substantially equivalent to K140094 (Eneura Therapeutics, LLC, 2014) after a 265-day review. Its family tree reaches back 2 generations to 2013. 2 later devices descend from it.
- Decided
- Jun 26, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- OKP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130022 (2013). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN130022 Neuralieve Cerena Transcranial Magnetic StimulatorEneura Therapeutics · 2013
- 1 generation backK140094 Springtms Total Migraine SystemEneura Therapeutics, LLC · 2014
- This deviceK162797 SpringTMSEneura, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK182976 SpringTMSEneura®, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK230358 SAVI Dual (TM) Migraine TherapyEneura, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130022 | Neuralieve Cerena Transcranial Magnetic Stimulator | Eneura Therapeutics | 2013 | — |
| −1 | K140094 | Springtms Total Migraine System | Eneura Therapeutics, LLC | 2014 | — |
| 0 (this device) | K162797 | SpringTMS | Eneura, Inc. | 2017 | — |
| +1 | K182976 | SpringTMS | Eneura®, Inc. | 2019 | — |
| +2 | K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K140094 | Springtms Total Migraine SystemSummary page 5…Same Manufacturer eNeura Inc. eNeura Inc. Same 510(k) # Not Assigned K140094 N/A Regulation 21 CFR§882.5808 21 CFR§882.5808 Same Number… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182976 | SpringTMS | 2019 | 1 |
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 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182976 (Eneura®, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K140094.
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. 2017, 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 Inc. SpringTMS® is indicated for the acute and prophylactic treatment of migraine headache.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162797 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162797: SpringTMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162797
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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