De Novo · Granted
GrantedNeuralieve Cerena Transcranial Magnetic Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eneura Therapeutics · OKP Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Granted on Dec 13, 2013 as a new device type through De Novo after a 283-day review. 5 later devices descend from it.
- Decided
- Dec 13, 2013
- Review
- 283 days
- Class
- Class II
- Product code
- OKP
- Recalls
- None
5 later devices descend from it, 1 citing it directly.
- This deviceDEN130022 Neuralieve Cerena Transcranial Magnetic StimulatorEneura Therapeutics · 2013
- Descendant · cites it directly · 4 of its ownK140094 Springtms Total Migraine SystemEneura Therapeutics, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK162797 SpringTMSEneura, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK182976 SpringTMSEneura®, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK230358 SAVI Dual (TM) Migraine TherapyEneura, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK161663 sTMS miniEneura, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K140094Springtms Total Migraine SystemEneura Therapeutics, LLC · 2014 · cites it directly4descendants
- K162797SpringTMSEneura, Inc. · 2017 · 2 generations on2descendants
- K182976SpringTMSEneura®, Inc. · 2019 · 3 generations on1descendant
- K230358SAVI Dual (TM) Migraine TherapyEneura, Inc. · 2023 · 4 generations on0descendants
- K161663sTMS miniEneura, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130022 | Neuralieve Cerena Transcranial Magnetic Stimulator | Eneura Therapeutics | 2013 | — |
| +1 | K140094 | Springtms Total Migraine System | Eneura Therapeutics, LLC | 2014 | — |
| +2 | K162797 | SpringTMS | Eneura, Inc. | 2017 | — |
| +3 | K182976 | SpringTMS | Eneura®, Inc. | 2019 | — |
| +4 | K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023 | — |
| +2 | K161663 | sTMS mini | Eneura, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140094 | Springtms Total Migraine System | 2014 | 4 |
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?
- Of its descendants, K140094 (Eneura Therapeutics, LLC, 2014) has gone furthest, with 4 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. 2013, 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?
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/DEN130022 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130022: Neuralieve Cerena Transcranial Magnetic Stimulator.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130022
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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