The Magstim Company , Ltd.: FDA clearances and approvals
The Magstim Company , Ltd. has 13 FDA 510(k) clearances (first 1992, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time: 166 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 185 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, The Magstim Company , Ltd.'s cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ETN | Stimulator, Nerve | 9 | 9 |
| GWF | Stimulator, Electrical, Evoked Response | 3 | 3 |
| OBP | Transcranial Magnetic Stimulator | 1 | 1 |
Review panels
- Ear, Nose and Throat (9)
- Neurology (4)
Most recent The Magstim Company , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | OBP | 2023-10-25 | 90 |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | GWF | 2013-08-23 | 185 |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | ETN | 2009-07-29 | 268 |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | GWF | 2008-12-08 | 287 |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | ETN | 2007-12-12 | 212 |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | GWF | 2005-12-21 | 166 |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | ETN | 2005-12-14 | 35 |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | ETN | 1999-05-19 | 12 |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | ETN | 1998-08-05 | 202 |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | ETN | 1997-05-14 | 161 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Magstim Company , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does The Magstim Company , Ltd. have?
The Magstim Company , Ltd. has 13 FDA 510(k) clearances (first 1992, latest 2023), across 3 product codes in 2 review panels.
How long does FDA take to clear The Magstim Company , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across The Magstim Company , Ltd.'s cleared 510(k)s is 166 days.
What devices does The Magstim Company , Ltd. make?
Its most frequent FDA product codes are ETN (Stimulator, Nerve, 9); GWF (Stimulator, Electrical, Evoked Response, 3); OBP (Transcranial Magnetic Stimulator, 1).
Has The Magstim Company , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Magstim Company , Ltd. Related entities may recall under other names.
Next steps
- See all 13 The Magstim Company , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ETN, The Magstim Company , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.