510(k) · Cleared
ClearedOrion Nasal Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bird Products Corp. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 22, 2002 as substantially equivalent to K990856 (Bird Products Corp., 2000) after a 77-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- May 22, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930656 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930656 Sullivan Iii Nasal Cpap SystemRescare, Ltd. · 1994
- 1 generation backK990856 Heritage Nasal Cpap System, Model P/N 15682Bird Products Corp. · 2000
- This deviceK020730 Orion Nasal Cpap SystemBird Products Corp. · 2002
- Descendant · cites it directly · 0 of its ownK022192 Pegasus Nasal Cpap SystemSensor Medics Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K022192Pegasus Nasal Cpap SystemSensor Medics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930656 | Sullivan Iii Nasal Cpap System | Rescare, Ltd. | 1994 | — |
| −1 | K990856 | Heritage Nasal Cpap System, Model P/N 15682 | Bird Products Corp. | 2000 | — |
| 0 (this device) | K020730 | Orion Nasal Cpap System | Bird Products Corp. | 2002 | — |
| +1 | K022192 | Pegasus Nasal Cpap System | Sensor Medics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990856 | Heritage Nasal Cpap System, Model P/N 15682Summary page 1…ate Device: The Orion Nasal CPAP System is not significantly different from the predicate device, the Softaire/Alura Nasal CPAP System as cleared for market under 510(k) 990856. Summary of Performance Testing: Performance testing was conducted in the laboratory to confirm compliance to dev… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022192 | Pegasus Nasal Cpap System | 2003 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022192 (Sensor Medics Corp., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020730 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020730: Orion Nasal Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020730
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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