510(k) · Cleared
ClearedAF541 SE Full Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Sep 18, 2015 as substantially equivalent to K101129 (Respironics, Inc., 2010) after a 191-day review. Its family tree reaches back 7 generations to 1983. 1 of the 20 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 18, 2015
- Review
- 191 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K833786 (1983). 18 ancestors in all, the oldest K811102 (1981). 1 later device descends from it, 1 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 6 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 5 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 4 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- 3 generations backK072450 Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc. · 2007
- 2 generations backK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- 1 generation backK101129 Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010
- This deviceK150638 AF541 SE Full Face MaskRespironics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK243394 AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024
Class I recalls in this family
- K981072 Esprit Ventilator4 generations back · 1998
Most influential descendants
Showing 1 of 1 · See all- K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −6 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −5 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −4 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| −3 | K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | Respironics California, Inc. | 2007 | — |
| −2 | K092648 | Respironics Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| −1 | K101129 | Esprit Ventilator with AF531 SE Full Face Mask | Respironics, Inc. | 2010 | — |
| 0 (this device) | K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015 | — |
| +1 | K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 1 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
1 device in this family has 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K101129 | Esprit Ventilator with AF531 SE Full Face MaskSummary page 4…rence Classification Name / CBK – Continuous Ventilator (Anesthesiology) Product Code Predicate Device(s) AF531 SE Full Face Mask (K101129) Indication for Use The AF541 SE Full Face Mask is intended to provide a patient interface for application of… | 2010 |
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 |
|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | 2024 | 0 |
Has anything in its family been recalled? (1 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.
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243394 (Respironics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101129.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
This Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
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/K150638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150638: AF541 SE 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/K150638
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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