# K203546: gammaCore Sapphire

- Pathway: 510(k) (Traditional)
- Applicant: Electrocore, Inc.
- Decided: Feb 12, 2021 after 70 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: 6 generations back to DEN150048 (2017). 6 ancestors in all.
1 later device descends 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)
- K191830: gammaCore Sapphire, Electrocore, Inc. (2020) Summary page 6.

## Most influential descendants
- 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: * The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients. * The acute treatment of pain associated with migraine headache in adolescent (age 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.

Source page: https://510kreport.com/device/K203546
Methodology: https://510kreport.com/methodology