Brainlab: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Brainlab” (first 1992, latest 2025), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 268 days. 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 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 180 |
| 2024 | 0 | — |
| 2025 | 1 | 175 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Brainlab took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
Most recent Brainlab 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243810 | TraumaCad Neo (1.1) | QIH | 2025-06-04 | 175 |
| K231498 | TraumaCad Neo | LLZ | 2023-11-20 | 180 |
| K992916 | BRAINLAB STEREOTACTIC ARC | HAW | 2000-01-11 | 134 |
| K983660 | EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) | LHN | 1999-07-14 | 268 |
| K962939 | VECTORVISION | HAW | 1997-05-22 | 297 |
| K920880 | BRAINSCAN BRACHYTHERAPY MODULE | KXK | 1992-12-30 | 308 |
| K920879 | BRAINSCAN RADIOSURGERY MODULE | IYE | 1992-12-29 | 307 |
Recalls
openFDA lists no recalls under a recalling firm named Brainlab.
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.
- Brainlab AG (135 510(k)s)
- Brainlab Med. Computersysteme GmbH (5 510(k)s)
- Brainlab Medizinische Computersysteme GmbH (1 510(k)s)
- Brainlab SE (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brainlab?
FDA lists 7 510(k) clearances under the applicant name “Brainlab” (first 1992, latest 2025), across 6 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 Brainlab?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brainlab is 268 days.
Which FDA product codes appear under Brainlab?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 2); IYE (Accelerator, Linear, Medical, 1); KXK (Source, Brachytherapy, Radionuclide, 1).
Next steps
- See all 7 Brainlab clearances with predicates and recalls
- Run predicate analysis for product code HAW, Brainlab'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.