The Magstim Company , Ltd.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under 4 spellings of the applicant name “The Magstim Company , Ltd.” (first 1992, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 153 days. Since 2017 the median was 136 days, against 156 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 185 |
| 2014 | 0 | — |
| 2015 | 1 | 147 |
| 2016 | 0 | — |
| 2017 | 2 | 148 |
| 2018 | 2 | 134 |
| 2019 | 2 | 137 |
| 2020 | 0 | — |
| 2021 | 2 | 111 |
| 2022 | 0 | — |
| 2023 | 3 | 161 |
| 2024 | 1 | 93 |
| 2025 | 2 | 122 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name The Magstim Company , Ltd. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 12 | 12 |
| ETN | Stimulator, Nerve | 9 | 9 |
| GWF | Stimulator, Electrical, Evoked Response | 3 | 3 |
| PDQ | Neurosurgical Nerve Locator | 2 | 2 |
| QPL | Electromagnetic Stimulator, Pain Relief | 1 | 1 |
Review panels
- Neurology (17)
- Ear, Nose and Throat (9)
- Physical Medicine (1)
Most recent The Magstim Company , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | QPL | 2025-07-03 | 153 |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | OBP | 2025-03-17 | 90 |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | OBP | 2024-08-30 | 93 |
| 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 |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | OBP | 2023-03-16 | 161 |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | OBP | 2023-01-13 | 176 |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation | OBP | 2021-09-14 | 132 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | PDQ | 2021-03-17 | 90 |
| K183376 | HORIZON TMS Therapy System with Navigation | OBP | 2019-04-03 | 118 |
| K182853 | HORIZON TMS Therapy System | OBP | 2019-03-15 | 156 |
17 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2020-12-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 4 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- The Magstim Company , Ltd. (13)
- Magstim Company, Ltd. (10)
- The Magstim Company Limited (3)
- Magstim Company Limited (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Magstim Company Us, LLC (1 510(k)s)
- Magstim Corporation US (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Magstim Company , Ltd.?
FDA lists 27 510(k) clearances under 4 spellings of the applicant name “The Magstim Company , Ltd.” (first 1992, latest 2025), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Magstim Company , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Magstim Company , Ltd. is 153 days. Since 2017: 136 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under The Magstim Company , Ltd.?
The most frequent FDA product codes under this applicant name are OBP (Transcranial Magnetic Stimulator, 12); ETN (Stimulator, Nerve, 9); GWF (Stimulator, Electrical, Evoked Response, 3).
Next steps
- See all 27 The Magstim Company , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OBP, The Magstim Company , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.