510(k) · Cleared
ClearedPerformax SE Total Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 18, 2007 as substantially equivalent to K992969 (Respironics, Inc., 1999) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 1993. 7 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 95 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925920 (1993). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925920 Total Face MaskRespironics, Inc. · 1993
- 1 generation backK992969 Respironics Total Face MaskRespironics, Inc. · 1999
- This deviceK072588 Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 5 of its ownK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · cites it directly · 3 of its ownK101129 Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK150638 AF541 SE Full Face MaskRespironics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK251888 VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243394 AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly5descendants
- K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010 · cites it directly3descendants
- K150638AF541 SE Full Face MaskRespironics, Inc. · 2015 · 2 generations on1descendant
- K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026 · 2 generations on0descendants
- K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925920 | Total Face Mask | Respironics, Inc. | 1993 | — |
| −1 | K992969 | Respironics Total Face Mask | Respironics, Inc. | 1999 | — |
| 0 (this device) | K072588 | Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | 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 | — |
| +2 | K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015 | — |
| +2 | K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026 | — |
| +2 | K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 CBK? 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? (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 |
|---|---|---|---|
| * | K992969 | Respironics Total Face MaskSummary page 1…n-continuous (respirator) Proprietary Name Respironics Performax SE Total Face Mask Predicate Device(s) Respironics Total Face Mask (K992969) - BZD Image 3 SE Face Mask (K023135) - CBK Reason for submission new device… | 1999 |
| * | K023135 | IMAGE3 SE Disposable Full Face MaskSummary page 1…s Performax SE Total Face Mask Predicate Device(s) Respironics Total Face Mask (K992969) - BZD Image 3 SE Face Mask (K023135) - CBK Reason for submission new device Substantial Equivalence The Respironics Performax SE Total Face M… | 2003 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092648 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K992969.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Performax SE Total 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 ventilator 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 multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072588: Performax SE Total 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/K072588
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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