# K180538: gammaCore Sapphire

- Pathway: 510(k) (Special)
- Applicant: Electrocore, LLC
- Decided: Mar 30, 2018 after 30 days
- Product code: PKR (Non-Invasive Vagus Nerve Stimulator - Headache)
- Device class: 2
- Regulation: 21 CFR 882.5892
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN150048 (2017). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172270: gammaCore-2, Eletrocore, LLC (2017) Summary page 5.

## Most influential descendants
- K182369: gammaCore Sapphire (2018), 3 descendants of its own
- K191830: gammaCore Sapphire (2020), 2 descendants of its own
- K203546: gammaCore Sapphire (2021), 1 descendant of its own
- K211856: gammaCore Sapphire (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K180538
Methodology: https://510kreport.com/methodology