# K990659: Nasal Aire

- Pathway: 510(k) (Traditional)
- Applicant: Breathing Technologies Corp.
- Decided: Nov 26, 1999 after 270 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 K945938 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945938: Respironics Monarch Mini Mask, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- K034053: TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040 (2004), 1 descendant of its own
- K051583: Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (2005), 0 descendants of its own

## Indications for use
Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space. The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a ventilator that contains an active exhalation valve or with an intentional leak port added into the breathing circuit

Source page: https://510kreport.com/device/K990659
Methodology: https://510kreport.com/methodology