510(k) · Cleared
ClearedHeritage Nasal Cpap System, Model P/N 15682
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 Jan 11, 2000 as substantially equivalent to K930656 (Rescare, Ltd., 1994) after a 302-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 11, 2000
- Review
- 302 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930656 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930656 Sullivan Iii Nasal Cpap SystemRescare, Ltd. · 1994
- This deviceK990856 Heritage Nasal Cpap System, Model P/N 15682Bird Products Corp. · 2000
- Descendant · cites it directly · 1 of its ownK020730 Orion Nasal Cpap SystemBird Products Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK022192 Pegasus Nasal Cpap SystemSensor Medics Corp. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930656 | Sullivan Iii Nasal Cpap System | Rescare, Ltd. | 1994 | — |
| 0 (this device) | K990856 | Heritage Nasal Cpap System, Model P/N 15682 | Bird Products Corp. | 2000 | — |
| +1 | K020730 | Orion Nasal Cpap System | Bird Products Corp. | 2002 | — |
| +2 | K022192 | Pegasus Nasal Cpap System | Sensor Medics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K930656 | Sullivan Iii Nasal Cpap SystemSummary page 4…evice The SoftAire Nasal CPAP System is not significantly different from the predicate device, the ResMed Sullivan III Nasal CPAP, first cleared for market under 510(k) K930656. Both devices utilize Blower type flow generators with the Bird SoftAire Nasal CPAP having a maximum working pressure of 22cmH,0.… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020730 | Orion Nasal Cpap System | 2002 | 1 |
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?
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 nasal CPAP unit 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 by a sleep study. The study obtains the optimum
level of pressure required to maintain an unobstructed airway, the positive pressure allows the
airway to stay open. The nasal CPAP unit is intended only for spontaneously breathing adult
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/K990856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990856: Heritage Nasal Cpap System, Model P/N 15682.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990856
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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