510(k) · Cleared
ClearedNasal Jacks Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 24, 2003 as substantially equivalent to K900164 (Puritan Bennett Corp., 1990) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1990. 10 of the 99 devices in its family, counting itself, have a Class I recall. 96 later devices descend from it.
- Decided
- Oct 24, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900164 (1990). 2 ancestors in all. 96 later devices descend from it, 2 citing it directly. 10 of the 99 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK900164 Airway Delivery & Management (Adam) Nasal Ventila.Puritan Bennett Corp. · 1990
- This deviceK032433 Nasal Jacks MaskResmed, Ltd. · 2003
- Descendant · cites it directly · 80 of its ownK042403 Mirage SwiftResmed, Ltd. · 2004
- Descendant · cites it directly · 41 of its ownK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- Descendant · 2 generations on · 38 of its ownK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- Descendant · 2 generations on · 36 of its ownK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- Descendant · 3 generations on · 26 of its ownK072940 Mirage MicroResmed, Ltd. · 2007
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 96 · See all- K042403Mirage SwiftResmed, Ltd. · 2004 · cites it directly80descendants
- K053352Comfortlite Nasal MaskRespironics, Inc. · 2006 · cites it directly41descendants
- K063122Mirage Quattro Full Face MaskResmed, Ltd. · 2007 · 2 generations on38descendants
- K082558Comfortlite Nasal MaskRespironics, Inc. · 2009 · 2 generations on36descendants
- K072940Mirage MicroResmed, Ltd. · 2007 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900164 | Airway Delivery & Management (Adam) Nasal Ventila. | Puritan Bennett Corp. | 1990 | — |
| 0 (this device) | K032433 | Nasal Jacks Mask | Resmed, Ltd. | 2003 | — |
| +1 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| +1 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| +2 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| +2 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| +3 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 2 |
| 2013 | 11 | 1 |
| 2014 | 3 | 0 |
| 2015 | 3 | 1 |
| 2016 | 5 | 2 |
| 2017 | 4 | 1 |
| 2018 | 3 | 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), 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.
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.
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? (2)
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 |
|---|---|---|---|
| * | K900164 | Airway Delivery & Management (Adam) Nasal Ventila.Summary page 1…e of submission Device Common Name/ Nasal Jacks Mask Classification Name: Predicate Devices: Primary predicate: ADAM" Interface System. K900164 Secondaw predicate: Mirage Nasal Mask (cleared in SULLIVANB… | 1990 |
| * | K980721 | Sullivan AutosetSummary page 1…tem. K900164 Secondaw predicate: Mirage Nasal Mask (cleared in SULLIVANB AUTOSETB Nasal CPAP System K980721) Device Description: The Nasal Jacks Mask is designed for adult patients for the delivery of non-invasive ventilatory support… | 1998 |
What descends from it? (96)
See all 962 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 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K120463Mojo, VerasealSleepnet Corporation · 2012 · 3 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 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K170924AirFit F20Resmed, Ltd. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 8 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?
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 Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multiple use for adult patients prescribed continuous positive aiway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032433 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032433: Nasal Jacks Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032433
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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