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 10, 2009 as substantially equivalent to K991648 (Respironics, Inc., 1999) and 1 other predicate after an 80-day review. Its family tree reaches back 3 generations to 1983. 1 of the 18 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 10, 2009
- Review
- 80 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. 5 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- 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 deviceK091843 Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · cites it directly · 4 of its ownK110405 Trublue Nasal MaskRespironics, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK122847 Kangaroo Nasal MaskRespironics, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK140980 TI Nasal MaskRespironics, Inc. · 2015 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK210844 DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
- Descendant · 5 generations on · 0 of its ownK253166 F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd. · 2026
Class I recalls in this family
- K140980 TI Nasal Mask3 generations on · 2015
Most influential descendants
Showing 5 of 5 · See all- K110405Trublue Nasal MaskRespironics, Inc. · 2011 · cites it directly4descendants
- K122847Kangaroo Nasal MaskRespironics, Inc. · 2013 · 2 generations on3descendants
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 3 generations on2descendants
- K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021 · 4 generations on1descendant
- K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd. · 2026 · 5 generations on0descendants
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) | K091843 | Comfort Twin Nasal Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +1 | K110405 | Trublue Nasal Mask | Respironics, Inc. | 2011 | — |
| +2 | K122847 | Kangaroo Nasal Mask | Respironics, Inc. | 2013 | — |
| +3 | K140980 | TI Nasal Mask | Respironics, Inc. | 2015 | Class I |
| +4 | K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021 | — |
| +5 | K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2021 | 1 | 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.
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 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…asal Mask Proprietary Name Respironics Comfort Twin Nasal Mask Predicate Device(s) Respironics Reusable II Contour Nasal Mask (K991 648). Resmed Mirage Activa (K032916) Reason for submission New device. Inclu… | 1999 |
| * | K032916 | Mirage Activa MaskSummary page 1…in Nasal Mask Predicate Device(s) Respironics Reusable II Contour Nasal Mask (K991 648). Resmed Mirage Activa (K032916) Reason for submission New device. Includes multi-patient, multi-use claim Substantial Equivalence. The C… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110405 | Trublue Nasal Mask | 2011 | 4 |
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.
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 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.
- Of its descendants, K110405 (Respironics, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 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. The mask is intended for single-
patient reuse in the home environment or multi-patient, multi-use in the
hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091843 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091843: Comfort Twin Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091843
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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