510(k) · Cleared
ClearedTrublue Nasal 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 Jun 6, 2011 as substantially equivalent to K092835 (Respironics Inc., Sleep & Home Respiratory Group, 2010) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1983. 1 of the 22 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jun 6, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K833786 (1983). 17 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 3 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 2 generations backK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
- 1 generation backK091843 Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- This deviceK110405 Trublue Nasal MaskRespironics, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK122847 Kangaroo Nasal MaskRespironics, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK140980 TI Nasal MaskRespironics, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK210844 DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
- Descendant · 4 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 Mask2 generations on · 2015
Most influential descendants
Showing 4 of 4 · See all- K122847Kangaroo Nasal MaskRespironics, Inc. · 2013 · cites it directly3descendants
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 2 generations on2descendants
- K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021 · 3 generations on1descendant
- K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −3 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −2 | K991648 | Reusable Contour II Nasal Mask | Respironics, Inc. | 1999 | — |
| −1 | K091843 | Comfort Twin Nasal Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| 0 (this device) | K110405 | Trublue Nasal Mask | Respironics, Inc. | 2011 | — |
| +1 | K122847 | Kangaroo Nasal Mask | Respironics, Inc. | 2013 | — |
| +2 | K140980 | TI Nasal Mask | Respironics, Inc. | 2015 | Class I |
| +3 | K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021 | — |
| +4 | 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 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092835 | Comfortgel Nasal MaskSummary page 1…ification Name IBZD - Ventilator, non-continuous (respirator) Product Code Predicate Device(s) Respironics ComfortGel Blue Nasal Mask (K092835) Respironics ComfortTwin Nasal Mask (K091 843) Device Description The TrueBlue Nasal Mas… | 2010 |
| * | K091843 | Comfort Twin Nasal MaskSummary page 1…roduct Code Predicate Device(s) Respironics ComfortGel Blue Nasal Mask (K092835) Respironics ComfortTwin Nasal Mask (K091 843) Device Description The TrueBlue Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-l… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122847 | Kangaroo Nasal Mask | 2013 | 3 |
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 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K122847 (Respironics, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K092835.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 TrueBlue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>661bs/3Okg) for whom CPAP or bi-level therapy has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110405: Trublue Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110405
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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