510(k) · Cleared
ClearedGolife 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 Feb 17, 2011 as substantially equivalent to K102502 (Respironics, Inc., 2010) after a 45-day review. Its family tree reaches back 5 generations to 1996. 2 of the 15 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 45 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945938 (1996). 9 ancestors in all, the oldest K900164 (1990). 5 later devices descend from it, 2 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 4 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 3 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 2 generations backK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- 1 generation backK102502 Golife Nasal MaskRespironics, Inc. · 2010
- This deviceK110008 Golife Nasal MaskRespironics, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK122847 Kangaroo Nasal MaskRespironics, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK121631 Simple T Nasal MaskRespironics, Inc. · 2012 · Recalled (Class I)
- 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
Most influential descendants
Showing 5 of 5 · See all- K122847Kangaroo Nasal MaskRespironics, Inc. · 2013 · cites it directly3descendants
- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · 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 |
|---|---|---|---|---|---|
| −5 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −4 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −3 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −2 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| −1 | K102502 | Golife Nasal Mask | Respironics, Inc. | 2010 | — |
| 0 (this device) | K110008 | Golife Nasal Mask | Respironics, Inc. | 2011 | — |
| +1 | K122847 | Kangaroo Nasal Mask | Respironics, Inc. | 2013 | — |
| +1 | K121631 | Simple T Nasal Mask | Respironics, Inc. | 2012 | Class I |
| +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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K102502 | Golife Nasal MaskSummary page 1…Classification Name IBZD - Ventilator, non-continuous (respirator) Product Code Predicate Device(s) Respironics GoLife Nasal Mask (K1 02502) Device Description The GoLife Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi- l… | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K122847 (Respironics, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K102502.
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 GoLife Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (OPAP) 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/K110008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110008: Golife 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/K110008
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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