510(k) · Cleared
ClearedRevolution Fullface Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc. (Dba Philips Respironics) · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jan 16, 2015 as substantially equivalent to K082866 (Respironics Inc., Sleep & Home Respiratory Group, 2009) and 1 other predicate after a 316-day review. Its family tree reaches back 3 generations to 1999. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 16, 2015
- Review
- 316 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984428 (1999). 6 ancestors in all, the oldest K954207 (1996). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK984428 Sullivan Autoset Nasal Cpap SystemResmed, Ltd. · 1999
- 2 generations backK023068 Papillon Mask SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2003
- 1 generation backK082866 Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- This deviceK140580 Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics) · 2015
Class I recalls in this family
- K082866 Revolutionfull Face Maskdirect predicate · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984428 | Sullivan Autoset Nasal Cpap System | Resmed, Ltd. | 1999 | — |
| −2 | K023068 | Papillon Mask Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2003 | — |
| −1 | K082866 | Revolutionfull Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| 0 (this device) | K140580 | Revolution Fullface Mask | Respironics Inc. (Dba Philips Respironics) | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K082866 | Revolutionfull Face MaskSummary page 5…ation Name / BZD – Ventilator, non-continuous (respirator) Product Code Predicate Device(s) Respironics Revolution Full Face Mask (K082866) Respironics Comfort Gel Full Face Mask (K073600) Device Description The Respironics… | 2009 |
| * | K073600 | Comfortgel Full Face MaskSummary page 5…Predicate Device(s) Respironics Revolution Full Face Mask (K082866) Respironics Comfort Gel Full Face Mask (K073600) Device Description The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K082866.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Revolution Full Face Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140580: Revolution Fullface Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140580
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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