De Novo · Granted
GrantedCefaly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stx-Med Sprl · PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Granted on Mar 11, 2014 as a new device type through De Novo after a 453-day review. 17 later devices descend from it.
- Decided
- Mar 11, 2014
- Review
- 453 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
17 later devices descend from it, 2 citing it directly.
- This deviceDEN120019 CefalyStx-Med Sprl · 2014
- Descendant · cites it directly · 16 of its ownK160237 CefalyCefaly Technology · 2016
- Descendant · 2 generations on · 13 of its ownK171446 Cefaly AcuteCefaly Technology · 2017
- Descendant · 2 generations on · 10 of its ownK173006 Cefaly DualCefaly Technology · 2017
- Descendant · 3 generations on · 7 of its ownK201895 Cefaly DualCefaly Technology · 2020
- Descendant · 3 generations on · 2 of its ownK212071 Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID…Cefaly Technology · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K160237CefalyCefaly Technology · 2016 · cites it directly16descendants
- K171446Cefaly AcuteCefaly Technology · 2017 · 2 generations on13descendants
- K173006Cefaly DualCefaly Technology · 2017 · 2 generations on10descendants
- K201895Cefaly DualCefaly Technology · 2020 · 3 generations on7descendants
- K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…Cefaly Technology · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| +1 | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| +2 | K171446 | Cefaly Acute | Cefaly Technology | 2017 | — |
| +2 | K173006 | Cefaly Dual | Cefaly Technology | 2017 | — |
| +3 | K201895 | Cefaly Dual | Cefaly Technology | 2020 | — |
| +3 | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx… | Cefaly Technology | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (17)
See all 172 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?
- Of its descendants, K160237 (Cefaly Technology, 2016) has gone furthest, with 16 descendants of its own.
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. 2014, 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 | — |
https://510kreport.com/device/DEN120019 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN120019: Cefaly.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN120019
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026