510(k) · Cleared
ClearedBreathx Nasal Pillow and Mask System, Model 011-0003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoffman Laboratories, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Aug 11, 2006 as substantially equivalent to K031883 (Sensor Medics Corp., 2003) and 1 other predicate after a 114-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Aug 11, 2006
- Review
- 114 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982530 (1998). 11 ancestors in all, the oldest K961783 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 3 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 2 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 1 generation backK050359 Ultra Mirage II MaskResmed, Ltd. · 2005
- This deviceK061099 Breathx Nasal Pillow and Mask System, Model 011-0003Hoffman Laboratories, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −3 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −2 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −1 | K050359 | Ultra Mirage II Mask | Resmed, Ltd. | 2005 | — |
| 0 (this device) | K061099 | Breathx Nasal Pillow and Mask System, Model 011-0003 | Hoffman Laboratories, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K031883 | Lyra Nasal MaskSummary page 1…assification(Name: Ventilator, non-continuous, non-life supporting Product Code(s): 21 CFR 868.5905 BZD Class: Class II Predicate Devices: · 510K Number: K031883 * Manufacturer: SensorMedics Corporation (VIASYS) * Trade Name: Lyra Nasal Interface * 510K Number:… | 2003 |
| * | K050359 | Ultra Mirage II MaskSummary page 1…· 510K Number: K031883 * Manufacturer: SensorMedics Corporation (VIASYS) * Trade Name: Lyra Nasal Interface * 510K Number: K050359 * Manufacturer: ResMed Limited * Trade Name: Ultra Mirage II Mask Reason for Submission: New Device… | 2005 |
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 8 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K031883.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BreatheX Nasal Interface System is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061099: Breathx Nasal Pillow and Mask System, Model 011-0003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061099
Report an extraction error
Are you the manufacturer?
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