Cefaly Technology: FDA clearances and approvals
Cefaly Technology has 6 FDA 510(k) clearances (first 2016, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time: 102 days. Since 2017 its median was 122 days, against 115 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 8 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 32 |
| 2017 | 2 | 92 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 83 |
| 2021 | 0 | — |
| 2022 | 1 | 529 |
| 2023 | 0 | — |
| 2024 | 1 | 211 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cefaly Technology's cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 6 | 6 |
Review panels
- Neurology (6)
Most recent Cefaly Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | PCC | 2024-07-18 | 211 |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | PCC | 2022-12-13 | 529 |
| K201895 | Cefaly Dual | PCC | 2020-09-29 | 83 |
| K173006 | Cefaly Dual | PCC | 2017-11-28 | 62 |
| K171446 | Cefaly Acute | PCC | 2017-09-15 | 122 |
| K160237 | Cefaly | PCC | 2016-03-04 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Cefaly Technology.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Cefaly Technology is the industry lead sponsor of 8 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06788977: External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy (Recruiting, started 2024-11-25)
- NCT03465904: A Phase III Trial of e-TNS for the Acute Treatment of Migraine (Completed, started 2018-04-10)
- NCT03217968: Abortive Treatment of Migraine With the Cefaly® Abortive Program Device (Completed, started 2017-08-10)
- NCT02590939: Acute Treatment of Migraine With e-TNS (Completed, started 2016-02-01)
- NCT02546362: Cefaly® Device in the Treatment of Patients With Fibromyalgia. (Completed, started 2015-12-03)
Frequently asked questions
How many FDA 510(k) clearances does Cefaly Technology have?
Cefaly Technology has 6 FDA 510(k) clearances (first 2016, latest 2024), across 1 product code in 1 review panel.
How long does FDA take to clear Cefaly Technology's 510(k)s?
The median time from FDA receipt to decision across Cefaly Technology's cleared 510(k)s is 102 days. Since 2017: 122 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Cefaly Technology make?
Its most frequent FDA product codes are PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, 6).
Has Cefaly Technology had device recalls?
openFDA lists no recalls under a recalling firm name matching Cefaly Technology. Related entities may recall under other names.
Next steps
- See all 6 Cefaly Technology clearances with predicates and recalls
- Run predicate analysis for product code PCC, Cefaly Technology's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.