510(k) · Cleared
ClearedSullivan Autoset Nasal Cpap System
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 Jul 26, 1999 after a 234-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 of the 136 devices in its family, counting itself, have a Class I recall. 135 later devices descend from it.
- Decided
- Jul 26, 1999
- Review
- 234 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
135 later devices descend from it, 6 citing it directly. 11 of the 136 devices in this family, counting this one, have a Class I recall.
- This deviceK984428 Sullivan Autoset Nasal Cpap SystemResmed, Ltd. · 1999
- Descendant · cites it directly · 113 of its ownK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- Descendant · cites it directly · 96 of its ownK023306 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- Descendant · cites it directly · 96 of its ownK023284 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- Descendant · 2 generations on · 93 of its ownK032916 Mirage Activa MaskResmed, Ltd. · 2003
- Descendant · 2 generations on · 80 of its ownK042403 Mirage SwiftResmed, Ltd. · 2004
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 135 · See all- K023244Mirage Full Face Mask Series 2Resmed, Ltd. · 2002 · cites it directly113descendants
- K023306Mirage Full Face Mask Series 2Resmed, Ltd. · 2002 · cites it directly96descendants
- K023284Mirage Full Face Mask Series 2Resmed, Ltd. · 2002 · cites it directly96descendants
- K032916Mirage Activa MaskResmed, Ltd. · 2003 · 2 generations on93descendants
- K042403Mirage SwiftResmed, Ltd. · 2004 · 2 generations on80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984428 | Sullivan Autoset Nasal Cpap System | Resmed, Ltd. | 1999 | — |
| +1 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| +1 | K023306 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| +1 | K023284 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| +2 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| +2 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 11 | 1 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 1 |
| 2013 | 14 | 1 |
| 2014 | 4 | 0 |
| 2015 | 6 | 2 |
| 2016 | 4 | 2 |
| 2017 | 5 | 1 |
| 2018 | 6 | 1 |
| 2019 | 3 | 2 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
11 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (135)
See all 1356 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 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.
- K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- 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
- K142554Revolution Full Face MaskRespironics, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 4 generations on · ◆ in the 2013 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
- K170924AirFit F20Resmed, Ltd. · 2018 · 4 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 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- Of its descendants, K023244 (Resmed, Ltd., 2002) has gone furthest, with 113 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 Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system’s labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984428: Sullivan Autoset 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/K984428
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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