De Novo · Granted
GrantedgammaCore Non-invasive Vagus Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrocore, LLC · PKR Non-Invasive Vagus Nerve Stimulator - Headache
Granted on Apr 14, 2017 as a new device type through De Novo after a 546-day review. 8 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 546 days
- Class
- Class II
- Product code
- PKR
- Recalls
- None
8 later devices descend from it, 1 citing it directly.
- This deviceDEN150048 gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC · 2017
- Descendant · cites it directly · 7 of its ownK171306 gammaCore-SElectrocore, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK172270 gammaCore-2Eletrocore, LLC · 2017
- Descendant · 3 generations on · 4 of its ownK180538 gammaCore SapphireElectrocore, LLC · 2018
- Descendant · 4 generations on · 3 of its ownK182369 gammaCore SapphireElectrocore, Inc. · 2018
- Descendant · 5 generations on · 2 of its ownK191830 gammaCore SapphireElectrocore, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K171306gammaCore-SElectrocore, LLC · 2017 · cites it directly7descendants
- K172270gammaCore-2Eletrocore, LLC · 2017 · 2 generations on5descendants
- K180538gammaCore SapphireElectrocore, LLC · 2018 · 3 generations on4descendants
- K182369gammaCore SapphireElectrocore, Inc. · 2018 · 4 generations on3descendants
- K191830gammaCore SapphireElectrocore, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | 2017 | — |
| +1 | K171306 | gammaCore-S | Electrocore, LLC | 2017 | — |
| +2 | K172270 | gammaCore-2 | Eletrocore, LLC | 2017 | — |
| +3 | K180538 | gammaCore Sapphire | Electrocore, LLC | 2018 | — |
| +4 | K182369 | gammaCore Sapphire | Electrocore, Inc. | 2018 | — |
| +5 | K191830 | gammaCore Sapphire | Electrocore, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 PKR? 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 PKR device
- #1 K203546 gammaCore Sapphirescore 5.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171306 | gammaCore-S | 2017 | 7 |
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, K171306 (Electrocore, LLC, 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All PKR devicesPKR Non-Invasive Vagus Nerve Stimulator - Headache: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PKR
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PKR
78in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKR
No recall names PKR since 2007.
Adverse event reports per year · PKR
1in 2018
MAUDE reports naming product code PKR, 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 | 3 | — | 0 | 0 |
| 2018 | 3 | 78 | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The gammaCore Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150048 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150048: gammaCore Non-invasive Vagus Nerve Stimulator.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150048
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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