510(k) · Cleared
ClearedPerformax 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 · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 19, 2007 as substantially equivalent to K992969 (Respironics, Inc., 1999) after a 96-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it.
- Decided
- Dec 19, 2007
- Review
- 96 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925920 (1993). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK925920 Total Face MaskRespironics, Inc. · 1993
- 1 generation backK992969 Respironics Total Face MaskRespironics, Inc. · 1999
- This deviceK072592 Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 4 of its ownK092043 Bipap Synchrony 2Respironics, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101130 Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK150639 AF541 EE Full Face MaskRespironics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK120562 Performax Pediatric EE Total Face MaskRespironics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK103395 Performax Total Face MaskRespironics, Inc. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092043Bipap Synchrony 2Respironics, Inc. · 2009 · cites it directly4descendants
- K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc. · 2010 · cites it directly1descendant
- K150639AF541 EE Full Face MaskRespironics, Inc. · 2015 · 2 generations on0descendants
- K120562Performax Pediatric EE Total Face MaskRespironics, Inc. · 2012 · 2 generations on0descendants
- K103395Performax Total Face MaskRespironics, Inc. · 2011 · cites it directly0descendants
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) | K072592 | Performax Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | — |
| +1 | K101130 | Bipap Synchrony 2 with AF531 Full Face Mask | Respironics, Inc. | 2010 | — |
| +2 | K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015 | — |
| +2 | K120562 | Performax Pediatric EE Total Face Mask | Respironics, Inc. | 2012 | — |
| +1 | K103395 | Performax Total Face Mask | Respironics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K992969 | Respironics Total Face MaskSummary page 1…nuous, non-life supporting Proprietary Name Respironics Performax Total Face Mask Predicate Device(s) Respironics Total Face Mask (K992969) - BZD Reason for submission modified device Substantial Equivalence The Respironics Performax Total Face… | 1999 |
What descends from it? (6)
4 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 2 ancestors has a recall.
- Of its descendants, K092043 (Respironics, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K992969.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Performax Total Face Mask is intended to provide an interface for
application of Respironics CPAP or BiPAP therapy to patients. For multi-patient
reuse in the home or hospital/institutional environment. The mask is to be used
on patients (>66 lbs/30 kg) for whom CPAP or BiPAP therapy has been
prescribed using a Respironics CPAP or BiPAP System. An exhalation port is
built into this mask so that a separate exhalation port is not required. This mask
is latex free and Di(2-ethylexyl)phthalate free.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072592 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072592: Performax Total Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072592
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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