510(k) · Cleared
Recalled · 2007Gel 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 Jan 31, 1996 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 23 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 31, 1996
- Review
- 146 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 4
- Predicates
- 0
22 later devices descend from it, 3 citing it directly. 3 of the 23 devices in this family, counting this one, have a Class I recall.
- This deviceK954207 Gel MaskRespironics, Inc. · 1996
- Descendant · cites it directly · 20 of its ownK073600 Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2008
- Descendant · 2 generations on · 10 of its ownK092835 Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010
- Descendant · cites it directly · 5 of its ownK090935 Minime Pediatric MaskSleepnet Corporation · 2009
- Descendant · 3 generations on · 4 of its ownK110405 Trublue Nasal MaskRespironics, Inc. · 2011
- Descendant · 4 generations on · 3 of its ownK122847 Kangaroo Nasal MaskRespironics, Inc. · 2013
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K073600Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2008 · cites it directly20descendants
- K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010 · 2 generations on10descendants
- K090935Minime Pediatric MaskSleepnet Corporation · 2009 · cites it directly5descendants
- K110405Trublue Nasal MaskRespironics, Inc. · 2011 · 3 generations on4descendants
- K122847Kangaroo Nasal MaskRespironics, Inc. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954207 | Gel Mask | Respironics, Inc. | 1996 | — |
| +1 | K073600 | Comfortgel Full Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2008 | — |
| +2 | K092835 | Comfortgel Nasal Mask | Respironics Inc., Sleep & Home Respiratory Group | 2010 | — |
| +1 | K090935 | Minime Pediatric Mask | Sleepnet Corporation | 2009 | — |
| +3 | K110405 | Trublue Nasal Mask | Respironics, Inc. | 2011 | — |
| +4 | K122847 | Kangaroo Nasal Mask | Respironics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 2 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1071-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1079-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1073-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Sep 29, 2003 | Not classified | Z-0178-04 | Other | product does not contain built in exhalation port |
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.
- K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K142554Revolution Full Face MaskRespironics, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K073600 (Respironics Inc., Sleep & Home Respiratory Group, 2008) has gone furthest, with 20 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K954207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954207: Gel Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954207
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026