510(k) · Cleared

Cleared

Pegasus Nasal Cpap System

K022192510(k) TraditionalCleared Jan 24, 2003203-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sensor Medics Corp. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jan 24, 2003 as substantially equivalent to K020730 (Bird Products Corp., 2002) and 1 other predicate after a 203-day review. Its family tree reaches back 3 generations to 1994.

Decided: Jan 24, 2003
Review: 203 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K930656 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK930656 Sullivan Iii Nasal Cpap SystemRescare, Ltd. · 1994
2 generations backK990856 Heritage Nasal Cpap System, Model P/N 15682Bird Products Corp. · 2000
1 generation backK020730 Orion Nasal Cpap SystemBird Products Corp. · 2002
This deviceK022192 Pegasus Nasal Cpap SystemSensor Medics Corp. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K930656	Sullivan Iii Nasal Cpap System	Rescare, Ltd.	1994	—
−2	K990856	Heritage Nasal Cpap System, Model P/N 15682	Bird Products Corp.	2000	—
−1	K020730	Orion Nasal Cpap System	Bird Products Corp.	2002	—
0 (this device)	K022192	Pegasus Nasal Cpap System	Sensor Medics Corp.	2003	—

FIG. 1 — Lineage of K022192, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZD device

#1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K020730	Orion Nasal Cpap System Summary page 2 …for setting or changing Titration. Comparison to Predicate Devices: The PegasusTMNasal CPAP System is primarily similar to the Bird Orion Nasal CPAP System [510(k) No. K0207301, but incorporates improved regulation of the delivered pressure as in two other devices, the Resprionics Remstar Pro [current ve…	Bird Products Corp.	2002	—
Kept off the family tree	K993307	FDA’s K993307 is Aria LX Cpap System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Respironics, Inc.	1999	—
*	K930656	Sullivan Iii Nasal Cpap System Summary page 2 …her devices, the Resprionics Remstar Pro [current version of the Aria LX, 510(k) No. Kg933071 and the Resmed S6 Elite [current version of the Sullivan I l l , 510(k) No. K9306561. Summary of Performance Testinq: Performance testing was conducted in the laboratory to confirm compliance to device specificat…	Rescare, Ltd.	1994	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	21	83	29	65
2008	17	108	2	67
2009	23	90	1	147
2010	12	122	0	143
2011	23	125	1	189
2012	21	133	0	139
2013	23	127	0	82
2014	14	172	0	86
2015	11	224	0	114
2016	12	217	0	118
2017	5	221	0	148
2018	5	280	0	101
2019	6	231	4 (4)	188
2020	6	137	0	126
2021	6	192	0	6,066
2022	4	253	0	90,768
2023	5	204	8 (7)	27,987
2024	10	132	0	68,262
2025	7	189	0	60,279
2026	10	214	2 (2)	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022192 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022192: Pegasus Nasal Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022192

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026