510(k) · Cleared
ClearedComfortlite 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 25, 2009 as substantially equivalent to K053352 (Respironics, Inc., 2006) after a 202-day review. Its family tree reaches back 3 generations to 1996. 7 of the 44 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Mar 25, 2009
- Review
- 202 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945938 (1996). 7 ancestors in all, the oldest K900164 (1990). 36 later devices descend from it, 5 citing it directly. 7 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 2 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 1 generation backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- This deviceK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- Descendant · cites it directly · 19 of its ownK102746 Mirage FXResmed, Ltd. · 2010
- Descendant · 2 generations on · 9 of its ownK123979 Quattro AirResmed, Ltd. · 2013 · Recalled
- Descendant · cites it directly · 9 of its ownK102502 Golife Nasal MaskRespironics, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK123789 Swift FX NanoResmed, Ltd. · 2013
- Descendant · 3 generations on · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 36 · See all- K102746Mirage FXResmed, Ltd. · 2010 · cites it directly19descendants
- K123979Quattro AirResmed, Ltd. · 2013 · 2 generations on9descendants
- K102502Golife Nasal MaskRespironics, Inc. · 2010 · cites it directly9descendants
- K123789Swift FX NanoResmed, Ltd. · 2013 · 2 generations on8descendants
- K132887Airfit N10Resmed, Ltd. · 2013 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −2 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −1 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| 0 (this device) | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| +1 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| +2 | K123979 | Quattro Air | Resmed, Ltd. | 2013 | 1 |
| +1 | K102502 | Golife Nasal Mask | Respironics, Inc. | 2010 | — |
| +2 | K123789 | Swift FX Nano | Resmed, Ltd. | 2013 | — |
| +3 | K132887 | Airfit N10 | Resmed, Ltd. | 2013 | Class I |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 1 |
| 2013 | 7 | 1 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 3 | 2 |
| 2017 | 3 | 1 |
| 2018 | 2 | 1 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
7 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 |
|---|---|---|---|
| * | K053352 | Comfortlite Nasal MaskSummary page 1…ass II Appropriate Classification Panel Anesthesiology Product Code BZD Predicate Devices Respironics ComfortLite Nasal Mask (K053352) Reason for submission Include a multi-patient re-use claim 02007 Respironics Inc. 02/27… | 2006 |
What descends from it? (36)
See all 365 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 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.
- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K170924AirFit F20Resmed, Ltd. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K161978AirFit N20Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K102746 (Resmed, Ltd., 2010) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K053352.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ComfortLite 2 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/K082558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082558: Comfortlite 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/K082558
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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