510(k) · Cleared
ClearedCefaly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefaly Technology · PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Cleared on Mar 4, 2016 as substantially equivalent to DEN120019 (Stx-Med Sprl, 2014) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 2014. 16 later devices descend from it.
- Decided
- Mar 4, 2016
- Review
- 32 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN120019 (2014). 16 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN120019 CefalyStx-Med Sprl · 2014
- This deviceK160237 CefalyCefaly Technology · 2016
- Descendant · cites it directly · 13 of its ownK171446 Cefaly AcuteCefaly Technology · 2017
- Descendant · cites it directly · 10 of its ownK173006 Cefaly DualCefaly Technology · 2017
- Descendant · 2 generations on · 7 of its ownK201895 Cefaly DualCefaly Technology · 2020
- Descendant · 2 generations on · 2 of its ownK212071 Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID…Cefaly Technology · 2022
- Descendant · 3 generations on · 1 of its ownK234029 CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K171446Cefaly AcuteCefaly Technology · 2017 · cites it directly13descendants
- K173006Cefaly DualCefaly Technology · 2017 · cites it directly10descendants
- K201895Cefaly DualCefaly Technology · 2020 · 2 generations on7descendants
- K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…Cefaly Technology · 2022 · 2 generations on2descendants
- K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| 0 (this device) | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| +1 | K171446 | Cefaly Acute | Cefaly Technology | 2017 | — |
| +1 | K173006 | Cefaly Dual | Cefaly Technology | 2017 | — |
| +2 | K201895 | Cefaly Dual | Cefaly Technology | 2020 | — |
| +2 | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx… | Cefaly Technology | 2022 | — |
| +3 | K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCC device
- #1 K201895 Cefaly Dualscore 16.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN120019 | CefalySummary page 4…sification Product Code: PCC Substantial Equivalency is claimed against the following legally marketed device: Cefaly®. The De Novo Number is DEN120019 and the 510(k) Number is K122566. Description of the device: Cefaly® device is a supraorbital transcu… | 2014 |
| * | DEN120019 | Cefaly 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. | 2014 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PCC devicesPCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PCC
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PCC
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCC
No recall names PCC since 2007.
Adverse event reports per year · PCC
2in 2025
MAUDE reports naming product code PCC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 4 | 88 | 0 | 7 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 5 | 211 | 0 | 6 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160237: Cefaly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160237
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026