# K022192: Pegasus Nasal Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Jan 24, 2003 after 203 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: 3 generations back to K930656 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020730: Orion Nasal Cpap System, Bird Products Corp. (2002) Summary page 2.
- K930656: Sullivan Iii Nasal Cpap System, Rescare, Ltd. (1994) Summary page 2.

## Cited in the summary but kept off the family tree
- K993307: Aria LX Cpap System, Respironics, Inc. (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The PegasusTMNasal CPAP System is intended for treatment of Adult Obstructive Sleep Apnea (OSA). The PegasusTMNasal CPAP System is intended only for spontsneously breathing patients.

Source page: https://510kreport.com/device/K022192
Methodology: https://510kreport.com/methodology