510(k) · Cleared
Recalled · Class I · 2023AirFit N20
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 Sep 28, 2017 as substantially equivalent to K161978 (Resmed, Ltd., 2016) after a 156-day review. Its family tree reaches back 11 generations to 1998. 3 of the 41 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Sep 28, 2017
- Review
- 156 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 11 generations to K982530 (1998). 37 ancestors in all, the oldest K900164 (1990). 3 later devices descend from it, 2 citing it directly. 3 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 7 generations between
- 3 generations backK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- 2 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 1 generation backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- This deviceK171212 AirFit N20Resmed, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK180497 Scone MaskResmed, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK223747 Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023
Show all 11 generations
- Root · 11 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 10 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 9 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 8 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 7 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 6 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 5 generations backK102746 Mirage FXResmed, Ltd. · 2010
- 4 generations backK123789 Swift FX NanoResmed, Ltd. · 2013
- 3 generations backK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- 2 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 1 generation backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- This deviceK171212 AirFit N20Resmed, Ltd. · 2017
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K180497Scone MaskResmed, Ltd. · 2018 · cites it directly1descendant
- K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation · 2026 · cites it directly0descendants
- K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −10 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −9 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −8 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −7 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −6 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −5 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| −4 | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| −3 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| −2 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| −1 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| 0 (this device) | K171212 | AirFit N20 | Resmed, Ltd. | 2017 | — |
| +1 | K180497 | Scone Mask | Resmed, Ltd. | 2018 | — |
| +1 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026 | — |
| +2 | K223747 | Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2023 | — |
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 |
|---|---|---|
| 2018 | 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? (1)
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 |
|---|---|---|---|
| * | K161978 | AirFit N20Summary page 4…ation & 21 CFR 868.5905, 73 BZD (Class II) Classification Name Accessory to Noncontinuous Ventilator (IPPB) Legally Marketed AirFit N20 (K161978) Predicate Devices Device Description The AirFit N20 is an externally placed vented respiratory mask… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0539-2024 | 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 19 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- 2 of the 37 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K180497 (Resmed, Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K161978.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit N20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171212: AirFit N20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171212
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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