510(k) · Cleared
ClearedgammaCore Sapphire
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 Mar 30, 2018 as substantially equivalent to K172270 (Eletrocore, LLC, 2017) after a 30-day review. Its family tree reaches back 3 generations to 2017. 4 later devices descend from it.
- Decided
- Mar 30, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- PKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150048 (2017). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN150048 gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC · 2017
- 2 generations backK171306 gammaCore-SElectrocore, LLC · 2017
- 1 generation backK172270 gammaCore-2Eletrocore, LLC · 2017
- This deviceK180538 gammaCore SapphireElectrocore, LLC · 2018
- Descendant · cites it directly · 3 of its ownK182369 gammaCore SapphireElectrocore, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK191830 gammaCore SapphireElectrocore, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK203546 gammaCore SapphireElectrocore, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK211856 gammaCore SapphireElectrocore, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K182369gammaCore SapphireElectrocore, Inc. · 2018 · cites it directly3descendants
- K191830gammaCore SapphireElectrocore, Inc. · 2020 · 2 generations on2descendants
- K203546gammaCore SapphireElectrocore, Inc. · 2021 · 3 generations on1descendant
- K211856gammaCore SapphireElectrocore, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Electrocore, LLC | 2017 | — |
| −2 | K171306 | gammaCore-S | Electrocore, LLC | 2017 | — |
| −1 | K172270 | gammaCore-2 | Eletrocore, LLC | 2017 | — |
| 0 (this device) | K180538 | gammaCore Sapphire | Electrocore, LLC | 2018 | — |
| +1 | K182369 | gammaCore Sapphire | Electrocore, Inc. | 2018 | — |
| +2 | K191830 | gammaCore Sapphire | Electrocore, Inc. | 2020 | — |
| +3 | K203546 | gammaCore Sapphire | Electrocore, Inc. | 2021 | — |
| +4 | K211856 | gammaCore Sapphire | Electrocore, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 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 |
|---|---|---|---|
| * | K172270 | gammaCore-2Summary page 5…Page 19 of 52 gammaCore® Sapphire Special 510(k) Premarket Application Predicate Device: gammaCore-2 K172270 Device Description: gammaCore Sapphire (gammaCore), like the predicate gammaCore-2 device, is a multi-use, hand-held, rechargeab… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182369 | gammaCore Sapphire | 2018 | 3 |
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 2 companies; a new generation was cleared every 4 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K182369 (Electrocore, Inc., 2018) has gone furthest, with 3 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. 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 Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire 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/K180538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180538: gammaCore Sapphire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180538
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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