510(k) · Cleared
ClearedgammaCore-S
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
Cleared on Jan 23, 2018 as substantially equivalent to K171306 (Electrocore, LLC, 2017) after a 78-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Jan 23, 2018
- Review
- 78 days
- Class
- Class II
- Product code
- PKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150048 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 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
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 |
|---|---|---|---|
| * | K171306 | gammaCore-SSummary page 5…me: External vagal nerve stimulator for headache Classification Status: Class II Product Codes: PKR, QAK Predicate Device: gammaCore-S K171306 Indication for Use: The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulat… | 2017 |
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 1 year and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K171306.
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. 2018, 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-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-S device is indicated for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173442: gammaCore-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173442
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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