# DEN120019: Cefaly

- Pathway: De Novo (Post-NSE)
- Applicant: Stx-Med Sprl
- Decided: Mar 11, 2014 after 453 days
- Product code: PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine)
- Device class: 2
- Regulation: 21 CFR 882.5891
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
0 of 18 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
- K160237: Cefaly (2016), 16 descendants of its own
- K171446: Cefaly Acute (2017), 13 descendants of its own
- K173006: Cefaly Dual (2017), 10 descendants of its own
- K201895: Cefaly Dual (2020), 7 descendants of its own
- K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (2022), 2 descendants of its own

Source page: https://510kreport.com/device/DEN120019
Methodology: https://510kreport.com/methodology