510(k) Report

510(k) · Cleared

Cleared

Swift FX Bella

K112489510(k) SpecialCleared Dec 7, 2011100-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Dec 7, 2011 as substantially equivalent to K090244 (Resmed, Ltd., 2009) and 6 other predicates after a 100-day review. Its family tree reaches back 6 generations to 1998.

Decided
Dec 7, 2011
Review
100 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
7

Its longest line of descent runs back 6 generations to K982530 (1998). 20 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2007: 2 other ancestors2005: 2 other ancestors2003: 2 other ancestors2002: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor1999: 1 other ancestor1990: 1 other ancestorK982530 · Sullivan Mirage Full Face Mask · Resmed, Ltd. · 1998K023244 · Mirage Full Face Mask Series 2 · Resmed, Ltd. · 2002K032916 · Mirage Activa Mask · Resmed, Ltd. · 2003K042403 · Mirage Swift · Resmed, Ltd. · 2004K063122 · Mirage Quattro Full Face Mask · Resmed, Ltd. · 2007K072940 · Mirage Micro · Resmed, Ltd. · 200719901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors K072940 · Mirage Micro · Resmed, Ltd. · 2007K063122 · Mirage Quattro Full Face Mask · Resmed, Ltd. · 2007K042403 · Mirage Swift · Resmed, Ltd. · 2004K032916 · Mirage Activa Mask · Resmed, Ltd. · 2003K023244 · Mirage Full Face Mask Series 2 · Resmed, Ltd. · 2002K982530 · Sullivan Mirage Full Face Mask · Resmed, Ltd. · 1998−50
  1. Root · 6 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
  2. 5 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
  3. 4 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
  4. 3 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
  5. 2 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
  6. 1 generation backK072940 Mirage MicroResmed, Ltd. · 2007
  7. This deviceK112489 Swift FX BellaResmed, Ltd. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K982530Sullivan Mirage Full Face MaskResmed, Ltd.1998—
−5K023244Mirage Full Face Mask Series 2Resmed, Ltd.2002—
−4K032916Mirage Activa MaskResmed, Ltd.2003—
−3K042403Mirage SwiftResmed, Ltd.2004—
−2K063122Mirage Quattro Full Face MaskResmed, Ltd.2007—
−1K072940Mirage MicroResmed, Ltd.2007—
0 (this device)K112489Swift FX BellaResmed, Ltd.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199610
199810
199910
200220
200320
200520
200720
200810
200910
FIG. 1 — Lineage of K112489, 1998–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in BZD? 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. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090244Swift FX
Summary page 1
…Name Accessory to Noncontinuous Ventilator (IPPB) Classification 21 CFR 868.5905, 73 BZD (Class 11) Primary predicate device Swift FX (K090244) Description The Swift FX Bella is a modified variant of the previously cleared Swift…
Resmed, Ltd.2009—
*K042403Mirage Swift
Summary page 1
…ome environment and multipatient re-use inthe hospital/institutional environment. Secondary predicate Mirage Swift (K042403), Ultra Mirage 11Mask (K050359), devices Mirage Quattro (K063122), Mirage Liberty (K06301 1),…
Resmed, Ltd.2004—
*K050359Ultra Mirage II Mask
Summary page 1
…multipatient re-use inthe hospital/institutional environment. Secondary predicate Mirage Swift (K042403), Ultra Mirage 11Mask (K050359), devices Mirage Quattro (K063122), Mirage Liberty (K06301 1), Mirage…
Resmed, Ltd.2005—
*K063122Mirage Quattro Full Face Mask
Summary page 1
…al/institutional environment. Secondary predicate Mirage Swift (K042403), Ultra Mirage 11Mask (K050359), devices Mirage Quattro (K063122), Mirage Liberty (K06301 1), Mirage Micro (K072940), Swift LT (K073638) Techno…
Resmed, Ltd.2007—
*K063011Mirage Liberty Full Face Mask
Summary page 1
…nt. Secondary predicate Mirage Swift (K042403), Ultra Mirage 11Mask (K050359), devices Mirage Quattro (K063122), Mirage Liberty (K06301 1), Mirage Micro (K072940), Swift LT (K073638) Technological Comparison with…
Resmed, Ltd.2007—
*K072940Mirage Micro
Summary page 1
…3), Ultra Mirage 11Mask (K050359), devices Mirage Quattro (K063122), Mirage Liberty (K06301 1), Mirage Micro (K072940), Swift LT (K073638) Technological Comparison with Primarypredicate Swift FX Xk090244) Charac…
Resmed, Ltd.2007—
*K073638Swift LT
Summary page 1
…ask (K050359), devices Mirage Quattro (K063122), Mirage Liberty (K06301 1), Mirage Micro (K072940), Swift LT (K073638) Technological Comparison with Primarypredicate Swift FX Xk090244) Characteristics The mod…
Resmed, Ltd.2008—

Also cleared against K090244: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
  • None of the 20 ancestors has a recall.
  • 6 other devices also cite its predicate K090244.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (2)—

What is it indicated for?

The Swift FX Bella 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 Bella is:

*to be used by adult patients (>66lb / >30kg) 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.

Also cleared against K090244

6 other devices cite the same predicate.

  • K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02…Suzhou Yuyue Medical Technology Co., Ltd. · 2021
  • K132013Swift AirResmed, Ltd. · 2013
  • K130686Nasal Comfort FreedomLakeview Sleep Center · 2013
  • K121642Wizard 230 Nasal Pilow MaskApex Medical Corp. · 2013
  • K123789Swift FX NanoResmed, Ltd. · 2013
  • K1034343B Flex-Lite3B Products, LLC · 2011

More from Resmed, Ltd.

103 FDA decisions under this applicant name. See the company

  • K183512Moore Park MaskResmed, Ltd. · 20191 Class I recall
  • K180497Scone MaskResmed, Ltd. · 2018
  • K172875Astral 100/150Resmed, Ltd. · 20182 Class I recalls
  • K170924AirFit F20Resmed, Ltd. · 20182 Class I recalls
  • K171212AirFit N20Resmed, Ltd. · 20171 Class I recall

Recent decisions in BZD

The BZD category page

  • K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd. · 2026
  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
  • K253553OrionResmed Corp · 2026
  • K254104ResScan EssentialsResmed Corp · 2026

https://510kreport.com/device/K112489 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112489: Swift FX Bella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112489

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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