510(k) · Cleared
ClearedRespironics Total 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 Nov 10, 1999 as substantially equivalent to K925920 (Respironics, Inc., 1993) after a 68-day review. Its family tree reaches back 1 generation to 1993. 15 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925920 (1993). 15 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925920 Total Face MaskRespironics, Inc. · 1993
- This deviceK992969 Respironics Total Face MaskRespironics, Inc. · 1999
- Descendant · cites it directly · 7 of its ownK072588 Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 6 of its ownK072592 Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 2 generations on · 5 of its ownK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · 2 generations on · 4 of its ownK092043 Bipap Synchrony 2Respironics, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK101129 Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly7descendants
- K072592Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly6descendants
- K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on5descendants
- K092043Bipap Synchrony 2Respironics, Inc. · 2009 · 2 generations on4descendants
- K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925920 | Total Face Mask | Respironics, Inc. | 1993 | — |
| 0 (this device) | K992969 | Respironics Total Face Mask | Respironics, Inc. | 1999 | — |
| +1 | K072588 | Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K072592 | Performax Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +2 | K092648 | Respironics Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +2 | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | — |
| +2 | K101129 | Esprit Ventilator with AF531 SE Full Face Mask | Respironics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 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 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 |
|---|---|---|---|
| * | K925920 | Total Face Mask Our OCR of the scanned summary read K925320, FDA’s number for A-Dec 2145 Duo Unit, Cusp (A-Dec, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Total Face Mask”. | 1993 |
What descends from it? (15)
See all 153 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?
- Its one ancestor has no recall.
- Of its descendants, K072588 (Respironics Inc., Sleep & Home Respiratory Group, 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.
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/K992969 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992969: Respironics Total Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992969
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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