Breas Medical, Inc.
Summary
- Total Recalls
- 6 (1 Class I)
- 510(k) Clearances
- 15
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2690-2024 | Class I | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilat | July 25, 2024 |
| Z-0405-2024 | Class II | with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accesso | October 13, 2023 |
| Z-1382-2022 | Class II | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the car | June 2, 2022 |
| Z-0943-2022 | Class II | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 | March 21, 2022 |
| Z-1352-2020 | Class II | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protect | January 28, 2020 |
| Z-2094-2015 | Class II | Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care | November 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242485 | EveryWare | May 20, 2025 |
| K242438 | Clearo | May 16, 2025 |
| K233452 | Vivo 45 LS | January 13, 2025 |
| K240779 | Vivo 3 | December 13, 2024 |
| K240778 | Vivo 1, Vivo 2 | December 13, 2024 |
| K193586 | Vivo 45 LS | January 27, 2021 |
| K160481 | Vivo 60 | November 9, 2016 |
| K090113 | BREAS VIVO 40 SYSTEM | May 14, 2009 |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | February 15, 2008 |
| K063476 | BREAS ISLEEP 20I | January 22, 2007 |
| K060657 | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. | August 18, 2006 |
| K061057 | BREAS ISLEEP 20+ | June 23, 2006 |
| K060546 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 | May 26, 2006 |
| K060790 | BREAS, MODEL HA01 | May 25, 2006 |
| K053607 | BREAS VIVO 40 SYSTEM | March 16, 2006 |