# K060790: Breas, Model HA01

- Pathway: 510(k) (Special)
- Applicant: Breas Medical AB
- Decided: May 25, 2006 after 63 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
Longest line of descent: 1 generation back to K002454 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002454: Breas HA50 Humidifier, Model HA50, Vital Signs, Inc. (2001) Summary page 1.

## Indications for use
The Breas HAOI is a humidifier intended to humidify gases delivered to a patient with a Breas CPAP device or a bilevel ventilator constructed to use an internal mask leak and no active exhalation valve.

Source page: https://510kreport.com/device/K060790
Methodology: https://510kreport.com/methodology