# Breas Medical AB

- Location (FDA's records): Molnlycke, SE
- FDA decisions: 15 (2006–2025): 15 510(k) clearances
- Product codes: MNT (4), BZD (3), NOU (3), MNS (2), MOD (1), NHJ (1), BTT (1)
- Predicates its devices cite: 19 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed, Ltd.: 5 (https://510kreport.com/company/resmed)
- Vital Signs, Inc.: 4 (https://510kreport.com/company/vital-signs)
- Respironics, Inc.: 3 (https://510kreport.com/company/respironics)
- Mallinckrodt, Inc.: 1 (https://510kreport.com/company/mallinckrodt)
- Respironics Inc., Sleep & Home Respiratory Group: 1 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Ge Healthcare, Breas Medical AB: 1 (https://510kreport.com/company/ge-healthcare-breas-medical)

## Firms that cite its devices most
- Respironics, Inc.: 2 (https://510kreport.com/company/respironics)
- Oconnell Regulatory Consultants, Inc.: 1 (https://510kreport.com/company/oconnell-regulatory-consultants)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Resmed Germany, Inc.: 1 (https://510kreport.com/company/resmed-germany)
- Human Design Medical, LLC: 1 (https://510kreport.com/company/human-design-medical)
- Ventus Medical, Inc.: 1 (https://510kreport.com/company/ventus-medical)

## Its most-cited devices
- K160481: Vivo 60 (2016), cited by 3
- K063476: Breas Isleep 20I (2007), cited by 2
- K193586: Vivo 45 LS (2021), cited by 2
- K090113: Breas Vivo 40 System (2009), cited by 2
- K071702: Breas Vivo Bilevel System, Model Vivo 40 (2008), cited by 1
- K053607: Breas Vivo 40 System (2006), cited by 1

## Recent decisions
- K242485: EveryWare (May 20, 2025)
- K242438: Clearo (May 16, 2025)
- K233452: Vivo 45 LS (Jan 13, 2025)
- K240779: Vivo 3 (Dec 13, 2024)
- K240778: Vivo 1, Vivo 2 (Dec 13, 2024)
- K193586: Vivo 45 LS (Jan 27, 2021)
- K160481: Vivo 60 (Nov 9, 2016)
- K090113: Breas Vivo 40 System (May 14, 2009)

Source page: https://510kreport.com/company/breas-medical