510(k) · Cleared
ClearedAirway Delivery & Management (Adam) Nasal Ventila.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Jan 26, 1990 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 of the 108 devices in its family, counting itself, have a Class I recall. 107 later devices descend from it.
- Decided
- Jan 26, 1990
- Review
- 14 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 0
107 later devices descend from it, 4 citing it directly. 10 of the 108 devices in this family, counting this one, have a Class I recall.
- This deviceK900164 Airway Delivery & Management (Adam) Nasal Ventila.Puritan Bennett Corp. · 1990
- Descendant · cites it directly · 96 of its ownK032433 Nasal Jacks MaskResmed, Ltd. · 2003
- Descendant · 2 generations on · 80 of its ownK042403 Mirage SwiftResmed, Ltd. · 2004
- Descendant · 2 generations on · 41 of its ownK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- Descendant · 3 generations on · 38 of its ownK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- Descendant · 3 generations on · 36 of its ownK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 107 · See all- K032433Nasal Jacks MaskResmed, Ltd. · 2003 · cites it directly96descendants
- K042403Mirage SwiftResmed, Ltd. · 2004 · 2 generations on80descendants
- K053352Comfortlite Nasal MaskRespironics, Inc. · 2006 · 2 generations on41descendants
- K063122Mirage Quattro Full Face MaskResmed, Ltd. · 2007 · 3 generations on38descendants
- K082558Comfortlite Nasal MaskRespironics, Inc. · 2009 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900164 | Airway Delivery & Management (Adam) Nasal Ventila. | Puritan Bennett Corp. | 1990 | — |
| +1 | K032433 | Nasal Jacks Mask | Resmed, Ltd. | 2003 | — |
| +2 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| +2 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| +3 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| +3 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 2 |
| 2013 | 13 | 1 |
| 2014 | 4 | 0 |
| 2015 | 3 | 1 |
| 2016 | 5 | 2 |
| 2017 | 4 | 1 |
| 2018 | 4 | 1 |
| 2019 | 3 | 2 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
10 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (107)
See all 1074 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K183512Moore Park MaskResmed, Ltd. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K120463Mojo, VerasealSleepnet Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K170924AirFit F20Resmed, Ltd. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 7 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- Of its descendants, K032433 (Resmed, Ltd., 2003) has gone furthest, with 96 descendants of its own.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 2025
MAUDE reports naming product code BYE, 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 | 1 | — | 4 | 8 |
| 2008 | 1 | — | 2 | 3 |
| 2009 | 3 | 155 | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K900164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900164: Airway Delivery & Management (Adam) Nasal Ventila..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900164
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026