# K020730: Orion Nasal Cpap System

- Pathway: 510(k) (Special)
- Applicant: Bird Products Corp.
- Decided: May 22, 2002 after 77 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: 2 generations back to K930656 (1994). 2 ancestors in all.
1 later device descends 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)
- K990856: Heritage Nasal Cpap System, Model P/N 15682, Bird Products Corp. (2000) Summary page 1.

## Most influential descendants
- K022192: Pegasus Nasal Cpap System (2003), 0 descendants of its own

## Indications for use
The Orion Nasal CPAP System is intended for treatment of Adult Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive Sleep Apnea is usually diagnosed through a sleep study. The study obtains the optimum level of pressure required to maintain airway pressure to the obstructed airway. The positive pressure allows the airway to stay open. The Orion CPAP System is intended only for spontaneously breathing patients.

Source page: https://510kreport.com/device/K020730
Methodology: https://510kreport.com/methodology