Tonica Elektronik A/S: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Tonica Elektronik A/S” (first 2006, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 121 days. Since 2017 the median was 120 days, against 145 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 142 |
| 2016 | 1 | 104 |
| 2017 | 5 | 30 |
| 2018 | 1 | 265 |
| 2019 | 0 | — |
| 2020 | 1 | 286 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 264 |
| 2024 | 0 | — |
| 2025 | 3 | 119 |
| 2026 | 1 | 120 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tonica Elektronik A/S took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 10 | 10 |
| GWF | Stimulator, Electrical, Evoked Response | 5 | 5 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 1 | 1 |
| QPL | Electromagnetic Stimulator, Pain Relief | 1 | 1 |
Review panels
- Neurology (17)
- Physical Medicine (1)
Most recent Tonica Elektronik A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | OBP | 2026-05-22 | 120 |
| K251125 | MagVenture TMS Therapy System | OBP | 2025-08-11 | 122 |
| K251119 | MagVenture TMS Therapy System | OBP | 2025-08-08 | 119 |
| K252032 | T65 (9016E061-) | OBP | 2025-07-30 | 30 |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | QPL | 2023-08-25 | 234 |
| K221544 | MagVenture TMS Atlas Neuro Navigation System | HAW | 2023-03-17 | 294 |
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | QCI | 2020-08-09 | 286 |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | OBP | 2018-08-14 | 265 |
| K172667 | MagVita TMS Therapy w/MagPro R20 | OBP | 2017-10-05 | 30 |
| K171967 | MagVita TMS Therapy System | OBP | 2017-07-25 | 25 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tonica Elektronik A/S.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tonica Elektronik A/S?
FDA lists 18 510(k) clearances under the applicant name “Tonica Elektronik A/S” (first 2006, latest 2026), across 5 product codes in 2 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 Tonica Elektronik A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tonica Elektronik A/S is 121 days. Since 2017: 120 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tonica Elektronik A/S?
The most frequent FDA product codes under this applicant name are OBP (Transcranial Magnetic Stimulator, 10); GWF (Stimulator, Electrical, Evoked Response, 5); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 18 Tonica Elektronik A/S clearances with predicates and recalls
- Run predicate analysis for product code OBP, Tonica Elektronik A/S'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.