# K182369: gammaCore Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Electrocore, Inc.
- Decided: Nov 27, 2018 after 88 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: 4 generations back to DEN150048 (2017). 4 ancestors in all.
3 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)
- K180538: gammaCore Sapphire, Electrocore, LLC (2018) Summary page 5.

## Most influential descendants
- 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
gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for: • 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. • The acute treatment of pain associated with migraine headache in adult patients.

Source page: https://510kreport.com/device/K182369
Methodology: https://510kreport.com/methodology