510(k) · Cleared
Recalled · Class II · 2016Quattro Air
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 Feb 27, 2013 as substantially equivalent to K063122 (Resmed, Ltd., 2007) and 2 other predicates after a 63-day review. Its family tree reaches back 7 generations to 1998. 2 of the 33 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2013
- Review
- 63 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K982530 (1998). 23 ancestors in all, the oldest K900164 (1990). 9 later devices descend from it, 3 citing it directly. 2 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 6 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 5 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 4 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 3 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 2 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 1 generation backK102746 Mirage FXResmed, Ltd. · 2010
- This deviceK123979 Quattro AirResmed, Ltd. · 2013
- Descendant · cites it directly · 6 of its ownK153563 AirFit F20Resmed, Ltd. · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK170924 AirFit F20Resmed, Ltd. · 2018 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK242547 AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK261262 Altis Full Face MaskRespironics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K153563AirFit F20Resmed, Ltd. · 2016 · cites it directly6descendants
- K170924AirFit F20Resmed, Ltd. · 2018 · 2 generations on3descendants
- K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd. · 2025 · 3 generations on1descendant
- K261262Altis Full Face MaskRespironics, Inc. · 2026 · 4 generations on0descendants
- K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −6 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −5 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −4 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −3 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −2 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −1 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| 0 (this device) | K123979 | Quattro Air | Resmed, Ltd. | 2013 | — |
| +1 | K153563 | AirFit F20 | Resmed, Ltd. | 2016 | Class I |
| +2 | K170924 | AirFit F20 | Resmed, Ltd. | 2018 | Class I |
| +3 | K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty, Ltd. | 2025 | — |
| +4 | K261262 | Altis Full Face Mask | Respironics, Inc. | 2026 | — |
| +2 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 1 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
2 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? (3)
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 |
|---|---|---|---|
| * | K063122 | Mirage Quattro Full Face MaskSummary page 1…Accessory to Noncontinuous Ventilator (IPPB) Classification 21 CIFR 868.5905, 73 BZD (Class 11) Predicate Devices Mirage Quattro (K063122) Mirage FX (K(1 02746). Ultra Mirage FFM (K(023244)… | 2007 |
| * | K102746 | Mirage FX | 2010 |
| * | K023244 | Mirage Full Face Mask Series 2Summary page 1…Predicate Devices Mirage Quattro (K063122) Mirage FX (K(1 02746). Ultra Mirage FFM (K(023244) Description The Quattro Air is an externally placed mask covering the mouth… | 2002 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2016 | Class II | Z-2550-2016 | Packaging process control | Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask. |
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.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K153563 (Resmed, Ltd., 2016) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K063122.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Quattro Air Mask System is a non-invasive accessory used for channelling air-flow (with or without supplemental oxygen) to a patient from a positive airway pressure device such as Continuous Positive Airway Pressure (CPAP) or bilevel system.
The Quattro Air Mask System is:
• to be used by patients (weighing >66 lb/30 kg) for whom positive airway pressure therapy has been prescribed.
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123979: Quattro Air.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123979
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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