510(k) · Cleared
ClearedComfort Twin Nasal 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 Sep 3, 2009 as substantially equivalent to K991648 (Respironics, Inc., 1999) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Sep 3, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K833786 (1983). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 2 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 1 generation backK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
- This deviceK091066 Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −2 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −1 | K991648 | Reusable Contour II Nasal Mask | Respironics, Inc. | 1999 | — |
| 0 (this device) | K091066 | Comfort Twin Nasal Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 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? (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 |
|---|---|---|---|
| * | K991648 | Reusable Contour II Nasal MaskSummary page 1…Nasal Mask Proprietary Name Respironics Comfort Twin Nasal Mask Predicate Device(s) Respironics Reusable Il Contour Nasal Mask (K991648) Resmed Mirage Activa (K032916) Reason for submission new device Substantial Equ… | 1999 |
| * | K032916 | Mirage Activa MaskSummary page 1…s Comfort Twin Nasal Mask Predicate Device(s) Respironics Reusable Il Contour Nasal Mask (K991648) Resmed Mirage Activa (K032916) Reason for submission new device Substantial Equivalence The Comfort Twin Nasal Mask has the following simil… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 12 ancestors has a recall.
- 8 other devices also cite its predicate K991648.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091066: Comfort Twin Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091066
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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