510(k) · Cleared
ClearedScone Mask
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 Jun 15, 2018 as substantially equivalent to K171212 (Resmed, Ltd., 2017) after a 109-day review. Its family tree reaches back 12 generations to 1998. 3 of the 40 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 15, 2018
- Review
- 109 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K982530 (1998). 38 ancestors in all, the oldest K900164 (1990). 1 later device descends from it, 1 citing it directly. 3 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 8 generations between
- 3 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 2 generations backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- 1 generation backK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- This deviceK180497 Scone MaskResmed, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK223747 Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023
Show all 12 generations
- Root · 12 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 11 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 10 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 9 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 8 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 7 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 6 generations backK102746 Mirage FXResmed, Ltd. · 2010
- 5 generations backK123789 Swift FX NanoResmed, Ltd. · 2013
- 4 generations backK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
- 3 generations backK153673 AirFit N20Resmed, Ltd. · 2016
- 2 generations backK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)
- 1 generation backK171212 AirFit N20Resmed, Ltd. · 2017 · Recalled (Class I)
- This deviceK180497 Scone MaskResmed, Ltd. · 2018
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967) · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −11 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −10 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −9 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −8 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −7 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −6 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| −5 | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| −4 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
| −3 | K153673 | AirFit N20 | Resmed, Ltd. | 2016 | — |
| −2 | K161978 | AirFit N20 | Resmed, Ltd. | 2016 | Class I |
| −1 | K171212 | AirFit N20 | Resmed, Ltd. | 2017 | Class I |
| 0 (this device) | K180497 | Scone Mask | Resmed, Ltd. | 2018 | — |
| +1 | 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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K171212 | AirFit N20Summary page 4…fication & 21 CFR 868.5905, 73 BZD (Class II) Classification Name Accessory to Noncontinuous Ventilator (IPPB) Legally Marketed AirFit N20 (K171212) Predicate Device Device Description The Scone Mask is an externally placed vented respiratory mask.… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223747 | Whitsundays Mask System | 2023 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K161978AirFit N20Resmed, Ltd. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- 3 of the 38 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K223747 (Resmed Pty Ltd (Registration Number: 3004604967), 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171212.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Scone Mask is intended to be used by patients weighing more than 66 1b (30 kg) who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home 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/K180497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180497: Scone Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180497
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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