# K160237: Cefaly

- Pathway: 510(k) (Special)
- Applicant: Cefaly Technology
- Decided: Mar 4, 2016 after 32 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
Longest line of descent: 1 generation back to DEN120019 (2014). 1 ancestor in all.
16 later devices descend from it; 4 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)
- DEN120019: Cefaly, Stx-Med Sprl (2014) Summary page 4.
- DEN120019: Cefaly, Stx-Med Sprl (2014). Our reading of the summary gave K122566, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120019, Cefaly (Stx-Med Sprl), granted Mar 11, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.

## Most influential descendants
- 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
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx (2024), 1 descendant of its own

## Indications for use
The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Source page: https://510kreport.com/device/K160237
Methodology: https://510kreport.com/methodology