510(k) · Cleared
ClearedPuresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models 11924-01, 11924-02, 11924-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 207, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 10, 2010 as substantially equivalent to K031935 (Tiara Medical Systems, Inc., 2004) and 2 other predicates after a 159-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Mar 10, 2010
- Review
- 159 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K982530 (1998). 21 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 7 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 6 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 5 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 4 generations backK063122 Mirage Quattro Full Face MaskResmed, Ltd. · 2007
- 3 generations backK072940 Mirage MicroResmed, Ltd. · 2007
- 2 generations backK081321 Modification to Mirage MicroResmed, Ltd. · 2008
- 1 generation backK090490 Mirage EchoResmed Corp · 2009
- This deviceK093124 Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal…Cardinal Health 207, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −7 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −6 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −5 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −4 | K063122 | Mirage Quattro Full Face Mask | Resmed, Ltd. | 2007 | — |
| −3 | K072940 | Mirage Micro | Resmed, Ltd. | 2007 | — |
| −2 | K081321 | Modification to Mirage Micro | Resmed, Ltd. | 2008 | — |
| −1 | K090490 | Mirage Echo | Resmed Corp | 2009 | — |
| 0 (this device) | K093124 | Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large… | Cardinal Health 207, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 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.
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 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 |
|---|---|---|---|
| * | K031935 | Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530Summary page 2…sually inspected for obstruction prior to use. Predicate Device Information: The predicate devices are Advantage Series II mask (K031935), Advantage Series mask (K(012207) and Mirage Echo (1(090490). Summary of Technological Characteristics of… | 2004 |
| * | K012207 | Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530Summary page 2…obstruction prior to use. Predicate Device Information: The predicate devices are Advantage Series II mask (K031935), Advantage Series mask (K(012207) and Mirage Echo (1(090490). Summary of Technological Characteristics of Device Compared to the Predicate D… | 2001 |
| * | K090490 | Mirage EchoSummary page 2…ce Information: The predicate devices are Advantage Series II mask (K031935), Advantage Series mask (K(012207) and Mirage Echo (1(090490). Summary of Technological Characteristics of Device Compared to the Predicate Device: The Puresom Nasal (CPAP) is the same dev… | 2009 |
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 12 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 21 ancestors has a recall.
- 1 other device also cites its predicate K031935.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093124: Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models 11924-01, 11924-02, 11924-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093124
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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