# DEN150048: gammaCore Non-invasive Vagus Nerve Stimulator

- Pathway: De Novo (Direct)
- Applicant: Electrocore, LLC
- Decided: Apr 14, 2017 after 546 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K171306: gammaCore-S (2017), 7 descendants of its own
- K172270: gammaCore-2 (2017), 5 descendants of its own
- K180538: gammaCore Sapphire (2018), 4 descendants of its own
- K182369: gammaCore Sapphire (2018), 3 descendants of its own
- K191830: gammaCore Sapphire (2020), 2 descendants of its own

## Indications for use
The gammaCore Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

Source page: https://510kreport.com/device/DEN150048
Methodology: https://510kreport.com/methodology