Braincool AB: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Braincool AB” (first 2017, latest 2023), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Since 2017 the median was 95 days, against 120 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 | 1 | 236 |
| 2018 | 1 | 95 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 20 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Braincool AB took a median 95 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 2 | 2 |
| NZE | Hyperthermia Monitor | 1 | 1 |
| QUA | Intraoral Cooling Device | 1 | 0 |
Review panels
- Cardiovascular (3)
- Dental (1)
Most recent Braincool AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232844 | The IQoolTM System | DWJ | 2023-10-04 | 20 |
| K180375 | The IQoolTM Warm System | DWJ | 2018-05-18 | 95 |
| K162523 | The IQool System | NZE | 2017-05-03 | 236 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210027 | De Novo | Intraoral Cooling Device | 2022-10-14 |
Recalls
openFDA lists no recalls under a recalling firm named Braincool AB.
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 Braincool AB?
FDA lists 3 510(k) clearances under the applicant name “Braincool AB” (first 2017, latest 2023), plus 1 De Novo decision, across 3 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 Braincool AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Braincool AB is 95 days. Since 2017: 95 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Braincool AB?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 2); NZE (Hyperthermia Monitor, 1); QUA (Intraoral Cooling Device, 1).
Next steps
- See all 3 Braincool AB clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Braincool AB'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.