Breas Medical AB: FDA clearances and approvals
Breas Medical AB has 15 FDA 510(k) clearances (first 2006, latest 2025), across 7 product codes in 1 review panel. Median 510(k) review time: 239 days. Since 2017 its median was 272 days, against 238 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Breas Medical AB.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 261 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 401 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 267 |
| 2025 | 3 | 273 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Breas Medical AB's cleared 510(k)s took a median 272 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNT | Sv70 Ventilator | 4 | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 | 3 |
| NOU | Continuous, Ventilator, Home Use | 3 | 3 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 1 | 1 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 1 | 1 |
Review panels
- Anesthesiology (15)
Most recent Breas Medical AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242485 | EveryWare | MOD | 2025-05-20 | 272 |
| K242438 | Clearo | NHJ | 2025-05-16 | 273 |
| K233452 | Vivo 45 LS | NOU | 2025-01-13 | 451 |
| K240779 | Vivo 3 | MNT | 2024-12-13 | 267 |
| K240778 | Vivo 1, Vivo 2 | MNS | 2024-12-13 | 267 |
| K193586 | Vivo 45 LS | NOU | 2021-01-27 | 401 |
| K160481 | Vivo 60 | NOU | 2016-11-09 | 261 |
| K090113 | BREAS VIVO 40 SYSTEM | MNT | 2009-05-14 | 113 |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | MNT | 2008-02-15 | 239 |
| K063476 | BREAS ISLEEP 20I | BZD | 2007-01-22 | 67 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-11-07.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Breas Medical AB have?
Breas Medical AB has 15 FDA 510(k) clearances (first 2006, latest 2025), across 7 product codes in 1 review panel.
How long does FDA take to clear Breas Medical AB's 510(k)s?
The median time from FDA receipt to decision across Breas Medical AB's cleared 510(k)s is 239 days. Since 2017: 272 days, versus 238 days for all cleared 510(k)s in the same product codes.
What devices does Breas Medical AB make?
Its most frequent FDA product codes are MNT (Sv70 Ventilator, 4); BZD (Ventilator, Non-Continuous (Respirator), 3); NOU (Continuous, Ventilator, Home Use, 3).
Has Breas Medical AB had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Breas Medical AB; the most recent began 2014-11-07. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Breas Medical AB clearances with predicates and recalls
- Run predicate analysis for product code MNT, Breas Medical AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.