Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PCC · Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
453 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254216 | Enso for Migraine | Hinge Health, Inc. | 2026-04-16 | 108 | 0 |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | 2024-11-06 | 57 | 0 |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024-07-18 | 211 | 0 |
| K232749 | DOOPANG | Ybrain, Inc. | 2024-06-11 | 277 | 0 |
| K233751 | Milieve (YPS-301BD) | Soterix Medical, Inc. | 2024-06-03 | 194 | 0 |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. | 2024-02-26 | 341 | 0 |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced w | Cefaly Technology | 2022-12-13 | 529 | 0 |
| K212106 | Relivion | Neurolief , Ltd. | 2021-08-02 | 27 | 0 |
| K211380 | Elexir | Nu Eyne Co., Ltd. | 2021-07-30 | 87 | 0 |
| K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 | 129 | 0 |
| K203419 | Relivion | Neurolief , Ltd. | 2021-02-16 | 89 | 0 |
| K201895 | Cefaly Dual | Cefaly Technology | 2020-09-29 | 83 | 0 |
| K192773 | ALLIVE | Nu Eyne Co., Ltd. | 2019-12-06 | 67 | 0 |
| K172450 | TENS device-HeadaTerm, eEspress | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-09-13 | 395 | 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 |
| DEN120019 | CEFALY | Stx-Med Sprl | 2014-03-11 | 453 | 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