510(k) · Cleared
ClearedKangaroo 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 Mar 6, 2013 as substantially equivalent to K110008 (Respironics, Inc., 2011) and 1 other predicate after a 169-day review. Its family tree reaches back 6 generations to 1996. 1 of the 32 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Mar 6, 2013
- Review
- 169 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945938 (1996). 28 ancestors in all, the oldest K833786 (1983). 3 later devices descend from it, 1 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 5 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 4 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 3 generations backK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- 2 generations backK102502 Golife Nasal MaskRespironics, Inc. · 2010
- 1 generation backK110008 Golife Nasal MaskRespironics, Inc. · 2011
- This deviceK122847 Kangaroo Nasal MaskRespironics, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK140980 TI Nasal MaskRespironics, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK210844 DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
- Descendant · 3 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 Maskcites it directly · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −5 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −4 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −3 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| −2 | K102502 | Golife Nasal Mask | Respironics, Inc. | 2010 | — |
| −1 | K110008 | Golife Nasal Mask | Respironics, Inc. | 2011 | — |
| 0 (this device) | K122847 | Kangaroo Nasal Mask | Respironics, Inc. | 2013 | — |
| +1 | K140980 | TI Nasal Mask | Respironics, Inc. | 2015 | Class I |
| +2 | K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021 | — |
| +3 | 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 |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110008 | Golife Nasal MaskSummary page 1…s 11 Classification Name I BZD - Ventilator, ndn-continuous (respirator) Product Code Predicate Device(s) Respironics GoLife Nasal Mask (K1 10008) Respironics TrueBlue Nasal Mask (K1 10405) Intended Use The Kangaroo Nasal Mask is intend… | 2011 |
| * | K110405 | Trublue Nasal MaskSummary page 1…irator) Product Code Predicate Device(s) Respironics GoLife Nasal Mask (K1 10008) Respironics TrueBlue Nasal Mask (K1 10405) Intended Use The Kangaroo Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140980 | TI Nasal Mask Class I | 2015 | 2 |
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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K140980 (Respironics, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K110008.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Kangaroo Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122847: Kangaroo 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/K122847
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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