510(k) · Cleared
ClearedAF541 EE Full Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 18, 2015 as substantially equivalent to K101130 (Respironics, Inc., 2010) after a 191-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Sep 18, 2015
- Review
- 191 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962517 (1997). 23 ancestors in all, the oldest K833786 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 7 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 6 generations backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- 5 generations backK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- 4 generations backK063533 Bipap SynchronyRespironics, Inc. · 2007
- 3 generations backK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- 2 generations backK092043 Bipap Synchrony 2Respironics, Inc. · 2009
- 1 generation backK101130 Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc. · 2010
- This deviceK150639 AF541 EE Full Face MaskRespironics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −7 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −6 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| −5 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| −4 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| −3 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| −2 | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | — |
| −1 | K101130 | Bipap Synchrony 2 with AF531 Full Face Mask | Respironics, Inc. | 2010 | — |
| 0 (this device) | K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K101130 | Bipap Synchrony 2 with AF531 Full Face MaskSummary page 4…eference Classification Name / BZD – Ventilator, non-continuous (respirator) Product Code Predicate Device(s) AF531 EE Full Face Mask (K101130) Indications for Use AF541 EE Leak 1 Mask The AF541 EE Leak 1 Full Face Mask is intended to provide an interface for ap… | 2010 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 23 ancestors have a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use i the hospital/institutional environment only. The mask is to be used on patients (=40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.
This Mask 1s intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment and single patient use in the home. The mask is to be used on patients (=401bs/20kg) for whom CPAP or bi-level therapy has been prescribed.
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/K150639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150639: AF541 EE Full Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150639
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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