Data / Medical devices / United States / Breas Medical, Inc.
Breas Medical, Inc.: FDA-registered device maker in N Billerica, MA, United States, 11 510(k) clearances
Breas Medical, Inc. is registered with the FDA (registration 3010817335) in N Billerica, MA, United States. It lists 13 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 19, 2025. 6 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010817335
- Address
- 16 Esquire Road, N Billerica, MA, United States, 01862
- Owner or operator
- BREAS MEDICAL, INC. (10046641)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 21, 2014
- Registered through
- 2027
- Brand names listed
- Clearo, Clearo Patient Circuit Americas, EveryWare, Vivo 1, Vivo 2, Vivo 3, Vivo 45 LS, Vivo 45LS, Vivo 55 and more
Devices it lists
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 |
| October 17, 2014 | K140929 | Z1 CPAP SYSTEM | BZD | Substantially Equivalent | Human Design Medical, LLC | accessdata.fda.gov |
| June 18, 2013 | K123144 | VIVO 50 | NOU | Substantially Equivalent | Ge Healthcare, Breas Medical AB | accessdata.fda.gov |
| February 22, 2013 | K121374 | ZI BLOWER | BZD | Substantially Equivalent | Deshum Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 25, 2024 | 95042 | Class I | Ongoing | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (2300 | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. | accessdata.fda.gov |
| October 13, 2023 | 93331 | Class II | Ongoing | with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilit | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation | accessdata.fda.gov |
| June 2, 2022 | 90433 | Class II | Ongoing | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained | accessdata.fda.gov |
| March 21, 2022 | 89776 | Class II | Terminated | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 | Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity | accessdata.fda.gov |
| January 28, 2020 | 84828 | Class II | Terminated | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional prot | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. | accessdata.fda.gov |
| May 8, 2018 | 80296 | Class III | Terminated | Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation | Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory To Continuous Ventilator (Respirator)
- All makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator
- All makers of Continuous, Ventilator, Home Use
- All makers of Ventilator, Continuous, Non-Life-Supporting
- All makers of Ventilator, Continuous, Facility Use
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
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.