Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Magstim Company , Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
166 daysmedian FDA review time
268 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System | The Magstim Company , Ltd. | 2023-10-25 | 90 | 0 |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | The Magstim Company , Ltd. | 2013-08-23 | 185 | 0 |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 2009-07-29 | 268 | 0 |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | The Magstim Company , Ltd. | 2008-12-08 | 287 | 0 |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | The Magstim Company , Ltd. | 2007-12-12 | 212 | 0 |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005- | The Magstim Company , Ltd. | 2005-12-21 | 166 | 0 |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | The Magstim Company , Ltd. | 2005-12-14 | 35 | 0 |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 1999-05-19 | 12 | 0 |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 1998-08-05 | 202 | 0 |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | The Magstim Company , Ltd. | 1997-05-14 | 161 | 0 |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | The Magstim Company , Ltd. | 1995-06-02 | 186 | 0 |
| K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MO | The Magstim Company , Ltd. | 1995-05-09 | 49 | 0 |
| K923056 | NEUROSIGN MODEL 100 | The Magstim Company , Ltd. | 1992-11-24 | 153 | 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