Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cefaly Technology — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
529 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024-07-18 | 211 | 0 |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced w | Cefaly Technology | 2022-12-13 | 529 | 0 |
| K201895 | Cefaly Dual | Cefaly Technology | 2020-09-29 | 83 | 0 |
| K173006 | Cefaly Dual | Cefaly Technology | 2017-11-28 | 62 | 0 |
| K171446 | Cefaly Acute | Cefaly Technology | 2017-09-15 | 122 | 0 |
| K160237 | Cefaly | Cefaly Technology | 2016-03-04 | 32 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda