510(k) · Cleared
ClearedgammaCore Sapphire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electrocore, Inc. · PKR Non-Invasive Vagus Nerve Stimulator - Headache
Cleared on Sep 10, 2021 as substantially equivalent to K203546 (Electrocore, Inc., 2021) after an 86-day review. Its family tree reaches back 7 generations to 2017.
- Decided
- Sep 10, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- PKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN150048 (2017). No later device cites it as a predicate yet.
- Root · 7 generations backDEN150048 gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC · 2017
- 6 generations backK171306 gammaCore-SElectrocore, LLC · 2017
- 5 generations backK172270 gammaCore-2Eletrocore, LLC · 2017
- 4 generations backK180538 gammaCore SapphireElectrocore, LLC · 2018
- 3 generations backK182369 gammaCore SapphireElectrocore, Inc. · 2018
- 2 generations backK191830 gammaCore SapphireElectrocore, Inc. · 2020
- 1 generation backK203546 gammaCore SapphireElectrocore, Inc. · 2021
- This deviceK211856 gammaCore SapphireElectrocore, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | 2017 | — |
| −6 | K171306 | gammaCore-S | Electrocore, LLC | 2017 | — |
| −5 | K172270 | gammaCore-2 | Eletrocore, LLC | 2017 | — |
| −4 | K180538 | gammaCore Sapphire | Electrocore, LLC | 2018 | — |
| −3 | K182369 | gammaCore Sapphire | Electrocore, Inc. | 2018 | — |
| −2 | K191830 | gammaCore Sapphire | Electrocore, Inc. | 2020 | — |
| −1 | K203546 | gammaCore Sapphire | Electrocore, Inc. | 2021 | — |
| 0 (this device) | K211856 | gammaCore Sapphire | Electrocore, Inc. | 2021 | — |
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
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 |
|---|---|---|---|
| * | K203546 | gammaCore SapphireSummary page 4…vagal nerve stimulator for headache Classification Status: Class II Product Codes: PKR, QAK Primary Predicate Device: gammaCore Sapphire, K203546 gammaCore Sapphire 510(k) Premarket Application… | 2021 |
| † | DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | 2017 |
| † | K182369 | gammaCore Sapphire | 2018 |
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 4 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 7 ancestors has a recall.
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. 2021, 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 Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for:
• The preventive treatment of migraine headache in adolescent (aged 12 and older) and adult patients
• The acute treatment of pain associated with migraine headache in adolescents (aged 12 and older) and adult patients
• Adjunctive use for the preventive treatment of cluster headache in adult patients
• The acute treatment of pain associated with episodic cluster headache in adult patients
• Treatment of hemicrania continua in adults
• Treatment of paroxysmal hemicrania in adults
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211856 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211856: gammaCore Sapphire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211856
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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