510(k) · Cleared
ClearedWhitsundays Mask System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Pty Ltd (Registration Number: 3004604967) · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jul 6, 2023 as substantially equivalent to K180497 (Resmed, Ltd., 2018) after a 204-day review. Its family tree reaches back 13 generations to 1998. 3 of the 40 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 6, 2023
- Review
- 204 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K982530 (1998). 39 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet. 3 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 9 generations between
- 3 generations backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- 2 generations backK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- 1 generation backK180497 Scone MaskResmed, Ltd. · 2018
- This deviceK223747 Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023
Show all 13 generations
- Root · 13 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 12 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 11 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 10 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 9 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 8 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 7 generations backK102746 Mirage FXResmed, Ltd. · 2010
- 6 generations backK123789 Swift FX NanoResmed, Ltd. · 2013
- 5 generations backK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- 4 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 3 generations backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- 2 generations backK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- 1 generation backK180497 Scone MaskResmed, Ltd. · 2018
- This deviceK223747 Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −12 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −11 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −10 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −9 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −8 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −7 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| −6 | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| −5 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| −4 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| −3 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| −2 | K171212 | AirFit N20 | Resmed, Ltd. | 2017 | Class I |
| −1 | K180497 | Scone Mask | Resmed, Ltd. | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K180497 | Scone MaskSummary page 4…ss II) Classification Name: Accessory to Noncontinuous Ventilator (IPPB) Product Code: BZD Predicate Device: Scone mask (K180497) Page 1 of 7… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K171212AirFit N20Resmed, Ltd. · 2017 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 39 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Whitsundays Mask System has two product variants:
• Whitsundays mask
• Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223747: Whitsundays Mask System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223747
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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