Data / Medical devices / Sweden / Breas Medical AB
Breas Medical AB: FDA-registered device maker in MOLNLYCKE Vastra Gotaland, Sweden, 8 510(k) clearances
Breas Medical AB is registered with the FDA (registration 9617566) in MOLNLYCKE Vastra Gotaland, Sweden. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 19, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617566
- FEI number
- 3003244771
- Address
- Foretagsvagen 1, MOLNLYCKE Vastra Gotaland, Sweden, 435 33
- Owner or operator
- Breas Medical (10046282)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- February 27, 2014
- Registered through
- 2027
- Brand names listed
- Clearo, Clearo Patient Circuit Americas, EveryWare, Single Patient Breathing Hose, Breathing Therapy Equipment Patient Circuit, Single Limb with Leakage Port, Disposable, B, T-Piece US, Ventilator Trolley, Vivo 1, Vivo 2, Vivo 3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory To Continuous Ventilator (Respirator) | MOD | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Continuous, Minimal Ventilatory Support, Facility Use Ventilator | MNT | 2 | Manufacturer | accessdata.fda.gov |
| Continuous, Ventilator, Home Use | NOU | 2 | Manufacturer | accessdata.fda.gov |
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | K232365 | Vivo 45 LS | CBK | Substantially Equivalent | Oconnell Regulatory Consultants, Inc. | accessdata.fda.gov |
| May 20, 2025 | K242485 | EveryWare | MOD | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
| May 16, 2025 | K242438 | Clearo | NHJ | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
| January 13, 2025 | K233452 | Vivo 45 LS | NOU | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
| December 13, 2024 | K240779 | Vivo 3 | MNT | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
| December 13, 2024 | K240778 | Vivo 1, Vivo 2 | MNS | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
| January 27, 2021 | K193586 | Vivo 45 LS | NOU | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
| November 9, 2016 | K160481 | Vivo 60 | NOU | Substantially Equivalent | Breas Medical AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 7, 2014 | 69760 | Class II | Terminated | Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care | Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode. | accessdata.fda.gov |
Compare with other makers
- All makers of Stand, Infusion
- All makers of Device, Positive Pressure Breathing, Intermittent
- All makers of Continuous, Ventilator, Home Use
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Ventilator, Continuous, Facility Use
Updated December 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.