# K951944: Nasalflair

- Pathway: 510(k) (Traditional)
- Applicant: Airways Ltd., Inc.
- Decided: Mar 28, 1997 after 702 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
The Airways Nasalflair is intended for use as a therapeutic device under the direction of qualified medical personnel. Nasalflair is used by patients who have been prescribed nCPAP as a treatment for Sleep Apnea. Nasalflair may be used with CPAP and BiPAP flow generators capable of generating 20 ± 2 cmH2O pressure via a 22mm I.D. main flow air supply tube.

Source page: https://510kreport.com/device/K951944
Methodology: https://510kreport.com/methodology