Magstim Company, Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Magstim Company, Ltd.” (first 2017, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 145 days. Since 2017 the median was 145 days, against 142 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 |
|---|---|---|
| 2017 | 2 | 148 |
| 2018 | 2 | 134 |
| 2019 | 2 | 137 |
| 2020 | 0 | — |
| 2021 | 2 | 111 |
| 2022 | 0 | — |
| 2023 | 2 | 168 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Magstim Company, Ltd. took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 8 | 8 |
| PDQ | Neurosurgical Nerve Locator | 2 | 2 |
Review panels
- Neurology (10)
Most recent Magstim Company, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | PDQ | 2018-11-09 | 149 |
| K180907 | HORIZON TMS Therapy System | OBP | 2018-08-03 | 119 |
| K171051 | HORIZON Therapy System | OBP | 2017-09-13 | 156 |
| K162935 | Rapid2 Therapy System | OBP | 2017-03-10 | 141 |
Recalls
openFDA lists no recalls under a recalling firm named Magstim Company, Ltd..
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.
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 Limited (1 510(k)s)
- 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 Magstim Company, Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Magstim Company, Ltd.” (first 2017, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Magstim Company, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Magstim Company, Ltd. is 145 days. Since 2017: 145 days, versus 142 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Magstim Company, Ltd.?
The most frequent FDA product codes under this applicant name are OBP (Transcranial Magnetic Stimulator, 8); PDQ (Neurosurgical Nerve Locator, 2).
Next steps
- See all 10 Magstim Company, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OBP, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.