510(k) · Cleared
Recalled · Class I · 2023Airfit N10
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 Dec 20, 2013 as substantially equivalent to K123789 (Resmed, Ltd., 2013) and 2 other predicates after a 95-day review. Its family tree reaches back 8 generations to 1998. 3 of the 42 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 20, 2013
- Review
- 95 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 8 generations to K982530 (1998). 34 ancestors in all, the oldest K900164 (1990). 7 later devices descend from it, 1 citing it directly. 3 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 7 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 6 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 5 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 4 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 3 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 2 generations backK102746 Mirage FXResmed, Ltd. · 2010
- 1 generation backK123789 Swift FX NanoResmed, Ltd. · 2013
- This deviceK132887 Airfit N10Resmed, Ltd. · 2013
- Descendant · cites it directly · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK180497 Scone MaskResmed, Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K153673AirFit N20Resmed, Ltd. · 2016 · cites it directly6descendants
- K161978AirFit N20Resmed, Ltd. · 2016 · 2 generations on5descendants
- K171212AirFit N20Resmed, Ltd. · 2017 · 3 generations on3descendants
- K180497Scone MaskResmed, Ltd. · 2018 · 4 generations on1descendant
- K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −7 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −6 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −5 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −4 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −3 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −2 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| −1 | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| 0 (this device) | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | — |
| +1 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| +2 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| +3 | K171212 | AirFit N20 | Resmed, Ltd. | 2017 | Class I |
| +4 | K180497 | Scone Mask | Resmed, Ltd. | 2018 | — |
| +4 | 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 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 1 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
3 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 |
|---|---|---|---|
| * | K123789 | Swift FX NanoSummary page 1…Classification & 21 CFR.868.5905, 73 BZD (Class 11) Classification Name Noncontinuous Ventilator (IPPB) Legally Marketed Swift FX Nano (K123789) Predicate Devices Ultra Mirage 11(K050359) SleepNet Mojo (K060273)… | 2013 |
| * | K050359 | Ultra Mirage II MaskSummary page 1…Classification Name Noncontinuous Ventilator (IPPB) Legally Marketed Swift FX Nano (K123789) Predicate Devices Ultra Mirage 11(K050359) SleepNet Mojo (K060273) Intended Use The AirF it N10 channels airflow non… | 2005 |
| * | K060273 | Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Summary page 1…PB) Legally Marketed Swift FX Nano (K123789) Predicate Devices Ultra Mirage 11(K050359) SleepNet Mojo (K060273) Intended Use The AirF it N10 channels airflow noninvasively to a patient from… | 2006 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153673 | AirFit N20 | 2016 | 6 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 20, 2023 | Class I | Z-0536-2024 | Device Design | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic… |
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 2.3 years on median.
- None of the 34 ancestors has a recall.
- Of its descendants, K153673 (Resmed, Ltd., 2016) has gone furthest, with 6 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. 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 AirFit N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit N10 is:
* to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
* intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
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/K132887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132887: Airfit N10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132887
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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