510(k) · Cleared
ClearedSwift FX Nano
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 Mar 29, 2013 as substantially equivalent to K090244 (Resmed, Ltd., 2009) and 2 other predicates after a 109-day review. Its family tree reaches back 7 generations to 1998. 3 of the 34 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Mar 29, 2013
- Review
- 109 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K982530 (1998). 25 ancestors in all, the oldest K900164 (1990). 8 later devices descend from it, 1 citing it directly. 3 of the 34 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 deviceK123789 Swift FX NanoResmed, Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016
- Descendant · 3 generations on · 5 of its ownK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- Descendant · 5 generations on · 1 of its ownK180497 Scone MaskResmed, Ltd. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K132887Airfit N10Resmed, Ltd. · 2013 · cites it directly7descendants
- K153673AirFit N20Resmed, Ltd. · 2016 · 2 generations on6descendants
- K161978AirFit N20Resmed, Ltd. · 2016 · 3 generations on5descendants
- K171212AirFit N20Resmed, Ltd. · 2017 · 4 generations on3descendants
- K180497Scone MaskResmed, Ltd. · 2018 · 5 generations on1descendant
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) | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| +1 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| +2 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| +3 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| +4 | K171212 | AirFit N20 | Resmed, Ltd. | 2017 | Class I |
| +5 | K180497 | Scone Mask | Resmed, Ltd. | 2018 | — |
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 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K090244 | Swift FXSummary page 1…ion Name Accessory to Noncontinuous Ventilator (IPPB) Classification 21 CFR 868.5905, 73 BZD (Class 11) Predicate Devices Swift FX (K090244). Mirage FX (K1 02746) Ultra Mirage 11(K050359)… | 2009 |
| * | K102746 | Mirage FXSummary page 1…Classification 21 CFR 868.5905, 73 BZD (Class 11) Predicate Devices Swift FX (K090244). Mirage FX (K1 02746) Ultra Mirage 11(K050359) Description The Swift FX Nano provides an int… | 2010 |
| * | K050359 | Ultra Mirage II MaskSummary page 1…ss 11) Predicate Devices Swift FX (K090244). Mirage FX (K1 02746) Ultra Mirage 11(K050359) Description The Swift FX Nano provides an interface such that airflow from a… | 2005 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132887 | Airfit N10 Class I | 2013 | 7 |
Has anything in its family been recalled? (3 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.
- K132887Airfit N10Resmed, Ltd. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
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 25 ancestors has a recall.
- Of its descendants, K132887 (Resmed, Ltd., 2013) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K090244.
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 Swift FX Nano channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift FX Nano 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 as stated in the FDA summary.
https://510kreport.com/device/K123789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123789: Swift FX Nano.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123789
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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