# K002454: Breas HA50 Humidifier, Model HA50

- Pathway: 510(k) (Abbreviated)
- Applicant: Vital Signs, Inc.
- Decided: Mar 7, 2001 after 209 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053607: Breas Vivo 40 System (2006), 25 descendants of its own
- K071702: Breas Vivo Bilevel System, Model Vivo 40 (2008), 24 descendants of its own
- K090113: Breas Vivo 40 System (2009), 23 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

Source page: https://510kreport.com/device/K002454
Methodology: https://510kreport.com/methodology