510(k) · Cleared
ClearedCEFALY Connected - OTC, CEFALY Connected - Rx
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 Jul 18, 2024 as substantially equivalent to K212071 (Cefaly Technology, 2022) after a 211-day review. Its family tree reaches back 6 generations to 2014. 1 later device descends from it.
- Decided
- Jul 18, 2024
- Review
- 211 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN120019 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backDEN120019 CefalyStx-Med Sprl · 2014
- 5 generations backK160237 CefalyCefaly Technology · 2016
- 4 generations backK171446 Cefaly AcuteCefaly Technology · 2017
- 3 generations backK173006 Cefaly DualCefaly Technology · 2017
- 2 generations backK201895 Cefaly DualCefaly Technology · 2020
- 1 generation backK212071 Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID…Cefaly Technology · 2022
- This deviceK234029 CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology · 2024
- Descendant · cites it directly · 0 of its ownK254216 Enso for MigraineHinge Health, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254216Enso for MigraineHinge Health, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| −5 | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| −4 | K171446 | Cefaly Acute | Cefaly Technology | 2017 | — |
| −3 | K173006 | Cefaly Dual | Cefaly Technology | 2017 | — |
| −2 | K201895 | Cefaly Dual | Cefaly Technology | 2020 | — |
| −1 | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx… | Cefaly Technology | 2022 | — |
| 0 (this device) | K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024 | — |
| +1 | K254216 | Enso for Migraine | Hinge Health, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…Summary page 5…Priority Number Information Cefaly® Dual Series (Cefaly® Dual CEFALY Primary K212071 Regulation Name: Enhanced with RFID - Transcutaneous… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254216 | Enso for Migraine | 2026 | 0 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K254216 (Hinge Health, Inc., 2026) has gone furthest, with 0 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. 2024, 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?
Cefaly Connected - OTC is indicated for:
1. Acute treatment of migraine with or without aura in patients 18 years of age or older
2. Preventative treatment of migraine in patients 18 years of age or older
Cefaly Connected - Rx is indicated for:
1. Acute treatment of migraine with or without aura in patients 18 years of age or older
2. Prophylactic treatment of migraine in patients 18 years of age or older
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K234029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234029: CEFALY Connected - OTC, CEFALY Connected - Rx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234029
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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