Company ยท SE
Breas Medical AB
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2025. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NOU | Continuous, Ventilator, Home Use | 8 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 1 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 2025 | K242485 | EveryWare Breas Medical AB, SE | MOD |
| May 16, 2025 | K242438 | Clearo Breas Medical AB, SE | NHJ |
| Jan 13, 2025 | K233452 | Vivo 45 LS Breas Medical AB, SE | NOU |
| Dec 13, 2024 | K240779 | Vivo 3 Breas Medical AB, SE | MNT |
| Dec 13, 2024 | K240778 | Vivo 1, Vivo 2 Breas Medical AB, SE | MNS |
| Jan 27, 2021 | K193586 | Vivo 45 LS Breas Medical AB, SE | NOU |
| Nov 9, 2016 | K160481 | Vivo 60 Breas Medical AB, SE | NOU |
| May 14, 2009 | K090113 | BREAS VIVO 40 SYSTEM Breas Medical AB, SE | MNT |
| Feb 15, 2008 | K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 Breas Medical AB, SE | MNT |
| Jan 22, 2007 | K063476 | BREAS ISLEEP 20I Breas Medical AB, SE | BZD |
| Aug 18, 2006 | K060657 | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. Breas Medical AB, SE | BZD |
| Jun 23, 2006 | K061057 | BREAS ISLEEP 20+ Breas Medical AB, SE | BZD |
| May 26, 2006 | K060546 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 Breas Medical AB, SE | MNS |
| May 25, 2006 | K060790 | BREAS, MODEL HA01 Breas Medical AB, SE | BTT |
| Mar 16, 2006 | K053607 | BREAS VIVO 40 SYSTEM Breas Medical AB, SE | MNT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2024 | Breas Medical, Inc. 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 Open, Classified |
NOU | K193586 |
| Nov 27, 2023 | Breas Medical, Inc. 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 betw Open, Classified |
NOU | K193586 K233452 |
| Jun 2, 2022 | Breas Medical, Inc. 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 Open, Classified |
NOU | K193586 |
| Mar 21, 2022 | Breas Medical, Inc. Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models
Article no 007384 Terminated |
CBK | None listed |
| Jan 28, 2020 | Breas Medical, Inc. 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 Terminated |
NOU | K160481 |
| Jul 16, 2015 | Breas Medical AB Breas Vivo 50 Home Care Ventilator
Product Usage:
Respiratory Care Terminated |
NOU | K123144 |