# K071773: Cpap Nasal Mask with Pillows

- Pathway: 510(k) (Traditional)
- Applicant: Lifesource
- Decided: Sep 12, 2007 after 75 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K900164 (1990). 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)
- K900164: Airway Delivery & Management (Adam) Nasal Ventila., Puritan Bennett Corp. (1990) Summary page 1.

## Indications for use
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use. Environment of use - hospital, sub-acute institutions, sleep laboratories and home

Source page: https://510kreport.com/device/K071773
Methodology: https://510kreport.com/methodology