510(k) · Cleared
ClearedAirView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 5, 2015 as substantially equivalent to K132371 (Resmed, Ltd., 2013) and 1 other predicate after a 118-day review. Its family tree reaches back 10 generations to 1997. 1 later device descends from it.
- Decided
- Nov 5, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K971260 (1997). 51 ancestors in all, the oldest K914085 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations between
- 3 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 2 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK132371 Easycare OnlineResmed, Ltd. · 2013
- This deviceK151901 AirViewResmed, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK242485 EveryWareBreas Medical AB · 2025
Show all 10 generations
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 9 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 8 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 7 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK050775 ResscanResmed, Ltd. · 2005
- 4 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 3 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 2 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK132371 Easycare OnlineResmed, Ltd. · 2013
- This deviceK151901 AirViewResmed, Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K242485EveryWareBreas Medical AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −9 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −8 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −7 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −4 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −3 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| −2 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −1 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| 0 (this device) | K151901 | AirView | Resmed, Ltd. | 2015 | — |
| +1 | K242485 | EveryWare | Breas Medical AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 CBK? 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K132371 | Easycare OnlineSummary page 5…Non-Life-Supporting (21 CFR 868.5895, Product Code 73 MNS) Predicate device(s) EasyCare Online - 510(k) number (K132371) ResScan - 510(k) number (K140054) Reason for submission Expanded… | 2013 |
| * | K140054 | RescanSummary page 5…uct Code 73 MNS) Predicate device(s) EasyCare Online - 510(k) number (K132371) ResScan - 510(k) number (K140054) Reason for submission Expanded Indications for Use Intended Use AirView is a web based solution for hea… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242485 | EveryWare | 2025 | 0 |
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 18 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 51 ancestors have a recall of any class.
- Of its descendants, K242485 (Breas Medical AB, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K132371.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
AirView is a web based solution for healthcare specialists intended to:
- assist in the diagnosis of sleep disordered breathing in adult patients through analysis of data recorded by an AirView compatible home sleep device.
- transfer and display machine and therapeutic information that has been transmitted remotely from the patient's therapy device. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device. AirView also provides remote settings capabilities for non-life support devices only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151901: AirView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151901
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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