510(k) Report

510(k) · Cleared

Cleared

AF531 Oro-Nasal SE Face Mask

K243394510(k) TraditionalCleared Dec 30, 202460-day reviewClass II21 CFR 868.5895

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Respironics, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Dec 30, 2024 as substantially equivalent to K150638 (Respironics, Inc., 2015) and 1 other predicate after a 60-day review. Its family tree reaches back 8 generations to 1983. 1 of the 20 devices in its family, counting itself, has a Class I recall.

Decided
Dec 30, 2024
Review
60 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K833786 (1983). 19 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2007: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors, 1 with a Class I recall11993: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestorK833786 · Microprocessor Ventilator 7200 · Puritan Bennett Corp. · 1983×2: 2 generations cleared close together, K951264 (1996), K955324 (1996) K982454 · Bipap Vision Ventilatory Support · Respironics, Inc. · 1998 · recalledK072450 · Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 · Respironics California, Inc. · 2007K092648 · Respironics Performax SE Total Face Mask · Respironics Inc., Sleep & Home Respiratory Group · 2009K101129 · Esprit Ventilator with AF531 SE Full Face Mask · Respironics, Inc. · 2010K150638 · AF541 SE Full Face Mask · Respironics, Inc. · 201519801990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 4 other ancestors, 1 with a Class I recall16 generations back: 4 other ancestors K150638 · AF541 SE Full Face Mask · Respironics, Inc. · 2015K101129 · Esprit Ventilator with AF531 SE Full Face Mask · Respironics, Inc. · 2010K092648 · Respironics Performax SE Total Face Mask · Respironics Inc., Sleep & Home Respiratory Group · 2009K072450 · Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 · Respironics California, Inc. · 2007K982454 · Bipap Vision Ventilatory Support · Respironics, Inc. · 1998 · recalledK955324 · Bipap S/T-D 30 System · Respironics, Inc. · 1996K951264 · Bipap Model S/T-D · Respironics, Inc. · 1996K833786 · Microprocessor Ventilator 7200 · Puritan Bennett Corp. · 1983−50
  1. Root · 8 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
  2. 7 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
  3. 6 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
  4. 5 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
  5. 4 generations backK072450 Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc. · 2007
  6. 3 generations backK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
  7. 2 generations backK101129 Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010
  8. 1 generation backK150638 AF541 SE Full Face MaskRespironics, Inc. · 2015
  9. This deviceK243394 AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024

Class I recalls in this family

  • K981072 Esprit Ventilator4 generations back · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K833786Microprocessor Ventilator 7200Puritan Bennett Corp.1983—
−7K951264Bipap Model S/T-DRespironics, Inc.1996—
−6K955324Bipap S/T-D 30 SystemRespironics, Inc.1996—
−5K982454Bipap Vision Ventilatory SupportRespironics, Inc.19982
−4K072450Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc.2007—
−3K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group2009—
−2K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.2010—
−1K150638AF541 SE Full Face MaskRespironics, Inc.2015—
0 (this device)K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199110
199310
199510
199821
199910
200010
200310
200710
FIG. 1 — Lineage of K243394, 1983–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K150638AF541 SE Full Face Mask
Summary page 5
…n Number 21 CFR 868.5895 Review Panel Anesthesiology Primary Predicate Device AF541 SE Full Face Mask 510(k) K150638 Product Code CBK Secondary Predicate Device AF531 SE Full Face Mask 510(k) K101129…
Respironics, Inc.2015—
*K101129Esprit Ventilator with AF531 SE Full Face Mask
Summary page 5
…ace Mask 510(k) K150638 Product Code CBK Secondary Predicate Device AF531 SE Full Face Mask 510(k) K101129 Product Code CBK Page 1 o…
Respironics, Inc.2010—

What descends from it?

No later submission names this one as a predicate yet.

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 41 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
  • 2 of the 19 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · CBK

4in 2025

2007: 112008: 182009: 122010: 142011: 132012: 172013: 52014: 52015: 72016: 42017: 62018: 42019: 82020: 52021: 62023: 52024: 92025: 42026 (partial year): 3
2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007: 142 days median2008: 115 days median2009: 122 days median2010: 150 days median2011: 192 days median2012: 207 days median2013: 277 days median2014: 439 days median2015: 266 days median2016: 323 days median2017: 280 days median2018: 183 days median2019: 435 days median2020: 176 days median2021: 267 days median2023: 309 days median2024: 203 days median2025: 163 days median2026 (partial year): 235 days median
2007high 439 (2014) · low 115 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CBK

14in 2024

2007: 172008: 232009: 82010: 92011: 122012: 2, 1 Class I2013: 5, 2 Class I2014: 5, 4 Class I2015: 6, 4 Class I2016: 4, 1 Class I2017: 12018: 3, 3 Class I2019: 14, 13 Class I2020: 42021: 21, 19 Class I2022: 8, 4 Class I2023: 4, 3 Class I2024: 14, 14 Class I2026 (partial year): 15, 13 Class I
2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007: 1,5312008: 1,9332009: 1,7662010: 1,7992011: 1,8772012: 5,5092013: 7,9212014: 7,6002015: 11,8762016: 16,0562017: 14,4512018: 9,8492019: 9,1002020: 11,0962021: 13,3222022: 15,9742023: 24,9282024: 20,3362025: 13,991
2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711142171,531
200818115231,933
20091212281,766
20101415091,799
201113192121,877
2012172072 (1)5,509
201352775 (2)7,921
201454395 (4)7,600
201572666 (4)11,876
201643234 (1)16,056
20176280114,451
201841833 (3)9,849
2019843514 (13)9,100
20205176411,096
2021626721 (19)13,322
20220—8 (4)15,974
202353094 (3)24,928
2024920314 (14)20,336
20254163013,991
2026323515 (13)—

What is it indicated for?

Medium and Large Size: The AF531 Oro-Nasal SE Face 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…

Read the full statement (188 words)

Medium and Large Size:

The AF531 Oro-Nasal SE Face 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 (>30 kg) who are appropriate candidates for noninvasive ventilation.

Small Size:

The AF531 Oro-Nasal SE Face 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 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.

Indications for use as stated in the FDA summary.

More from Respironics, Inc.

173 FDA decisions under this applicant name. See the company

  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K231313Therapy Mask 3100 NC/SPRespironics, Inc. · 2023
  • K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
  • K210386Magneto Nasal MaskRespironics, Inc. · 20211 Class I recall
  • K202142Sleepware G3Respironics, Inc. · 2020

Recent decisions in CBK

The CBK category page

  • K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
  • K252663Inbentus VersatileIconic Solutions by Murcia, SL · 2026
  • K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
  • K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
  • K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P…Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K243394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243394: AF531 Oro-Nasal SE 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/K243394

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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