Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magstim Company, Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
176 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, | Magstim Company, Ltd. | 2023-03-16 | 161 | 0 |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, | Magstim Company, Ltd. | 2023-01-13 | 176 | 0 |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, | Magstim Company, Ltd. | 2021-09-14 | 132 | 0 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2021-03-17 | 90 | 0 |
| K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | 2019-04-03 | 118 | 0 |
| K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019-03-15 | 156 | 0 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2018-11-09 | 149 | 0 |
| K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018-08-03 | 119 | 0 |
| K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017-09-13 | 156 | 0 |
| K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017-03-10 | 141 | 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