Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OKP · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
283 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023-05-16 | 95 | 0 |
| K182976 | SpringTMS | Eneura®, Inc. | 2019-02-25 | 122 | 0 |
| K162797 | SpringTMS | Eneura, Inc. | 2017-06-26 | 265 | 0 |
| K161663 | sTMS mini | Eneura, Inc. | 2016-08-23 | 68 | 0 |
| K140094 | SPRINGTMS TOTAL MIGRAINE SYSTEM | Eneura Therapeutics, LLC | 2014-05-21 | 127 | 0 |
| DEN130022 | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | Eneura Therapeutics | 2013-12-13 | 283 | 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