510(k) · Cleared
ClearedNasal Comfort Freedom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lakeview Sleep Center · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 16, 2013 as substantially equivalent to K090244 (Resmed, Ltd., 2009) and 1 other predicate after a 217-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Oct 16, 2013
- Review
- 217 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K982530 (1998). 21 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK982530 Sullivan Mirage Full Face MaskResmed, Ltd. · 1998
- 5 generations backK023244 Mirage Full Face Mask Series 2Resmed, Ltd. · 2002
- 4 generations backK032916 Mirage Activa MaskResmed, Ltd. · 2003
- 3 generations backK042403 Mirage SwiftResmed, Ltd. · 2004
- 2 generations backK073638 Swift LTResmed, Ltd. · 2008
- 1 generation backK090244 Swift FXResmed, Ltd. · 2009
- This deviceK130686 Nasal Comfort FreedomLakeview Sleep Center · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K982530 | Sullivan Mirage Full Face Mask | Resmed, Ltd. | 1998 | — |
| −5 | K023244 | Mirage Full Face Mask Series 2 | Resmed, Ltd. | 2002 | — |
| −4 | K032916 | Mirage Activa Mask | Resmed, Ltd. | 2003 | — |
| −3 | K042403 | Mirage Swift | Resmed, Ltd. | 2004 | — |
| −2 | K073638 | Swift LT | Resmed, Ltd. | 2008 | — |
| −1 | K090244 | Swift FX | Resmed, Ltd. | 2009 | — |
| 0 (this device) | K130686 | Nasal Comfort Freedom | Lakeview Sleep Center | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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.
Planning a device in BZD? 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 |
|---|---|---|---|
| * | K090244 | Swift FXSummary page 2…r, Nasal Comfort Freedom is substantially equivalent to the commercially available predicate devices ResMed Swift FX approved by the FDA under 510Ok number K090244, and Respironics GoLife Nasal Mask approved by the FDA under 510k number K102502. Table 1 shows a summary of the te… | 2009 |
| * | K102502 | Golife Nasal MaskSummary page 2…e predicate devices ResMed Swift FX approved by the FDA under 510Ok number K090244, and Respironics GoLife Nasal Mask approved by the FDA under 510k number K102502. Table 1 shows a summary of the technological characteristics of the Nasal Comfort Freedom compared to the predicat… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 21 ancestors has a recall.
- 6 other devices also cite its predicate K090244.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Nasal Comfort Freedom provides a conduit such that airflow from a positive pressure source is directed to a patients nose. The device Is intended for adult patients (>66 lb/30kg) for whom positive airway pressure has been prescribed. The device is single-patient re-use, and is intended for use in a clinical or home-use environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130686: Nasal Comfort Freedom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130686
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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