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 Dec 22, 2010 as substantially equivalent to K082558 (Respironics, Inc., 2009) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 1996. 2 of the 18 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Dec 22, 2010
- Review
- 112 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945938 (1996). 8 ancestors in all, the oldest K900164 (1990). 9 later devices descend from it, 3 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 3 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 2 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 1 generation backK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- This deviceK102502 Golife Nasal MaskRespironics, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK110008 Golife Nasal MaskRespironics, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK122847 Kangaroo Nasal MaskRespironics, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK121631 Simple T Nasal MaskRespironics, Inc. · 2012 · Recalled (Class I)
- 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K110008Golife Nasal MaskRespironics, Inc. · 2011 · cites it directly5descendants
- K122847Kangaroo Nasal MaskRespironics, Inc. · 2013 · 2 generations on3descendants
- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · 2 generations on3descendants
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 3 generations on2descendants
- K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −3 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −2 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −1 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| 0 (this device) | K102502 | Golife Nasal Mask | Respironics, Inc. | 2010 | — |
| +1 | K110008 | Golife Nasal Mask | Respironics, Inc. | 2011 | — |
| +2 | K122847 | Kangaroo Nasal Mask | Respironics, Inc. | 2013 | — |
| +2 | K121631 | Simple T Nasal Mask | Respironics, Inc. | 2012 | Class I |
| +3 | K140980 | TI Nasal Mask | Respironics, Inc. | 2015 | Class I |
| +4 | K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 2 | 0 |
| 2015 | 1 | 1 |
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K082558 | Comfortlite Nasal MaskSummary page 1…Classification Name IBZD - Ventilator, non-continuous (respirator) Product Code Predicate Device(s) Respironics ComfortLite Nasal Mask (K082558) Respironics Monarch Mini Mask (K945938) Device Description The GoLife Nasal Mask is int… | 2009 |
| * | K945938 | Respironics Monarch Mini MaskSummary page 1…rator) Product Code Predicate Device(s) Respironics ComfortLite Nasal Mask (K082558) Respironics Monarch Mini Mask (K945938) Device Description The GoLife Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi- l… | 1996 |
What descends from it? (9)
3 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 14 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K110008 (Respironics, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K082558.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 (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/K102502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102502: Golife 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/K102502
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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