510(k) · Cleared
ClearedEasycare Online
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Nov 22, 2013 as substantially equivalent to K123557 (Resmed, Ltd., 2013) and 1 other predicate after a 115-day review. Its family tree reaches back 9 generations to 1997. 8 later devices descend from it.
- Decided
- Nov 22, 2013
- Review
- 115 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K971260 (1997). 49 ancestors in all, the oldest K914085 (1991). 8 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 5 generations between
- 3 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 2 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 1 generation backK123557 Easycare OnlineResmed, Ltd. · 2013
- This deviceK132371 Easycare OnlineResmed, Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK152356 SapphireRespironics, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK181053 Care OrchestratorRespironics, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK151901 AirViewResmed, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK261360 EasyCare Tx 2Resmed Corp · 2026
- Descendant · cites it directly · 0 of its ownK251889 myAirResmed Corp · 2026
Show all 9 generations
- Root · 9 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 8 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 7 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 6 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 4 generations backK050775 ResscanResmed, Ltd. · 2005
- 3 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 2 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 1 generation backK123557 Easycare OnlineResmed, Ltd. · 2013
- This deviceK132371 Easycare OnlineResmed, Ltd. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152356SapphireRespironics, Inc. · 2016 · cites it directly4descendants
- K181053Care OrchestratorRespironics, Inc. · 2019 · 2 generations on1descendant
- K151901AirViewResmed, Ltd. · 2015 · cites it directly1descendant
- K261360EasyCare Tx 2Resmed Corp · 2026 · cites it directly0descendants
- K251889myAirResmed Corp · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −8 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −7 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −6 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −4 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −3 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −2 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| −1 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| 0 (this device) | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +1 | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| +2 | K181053 | Care Orchestrator | Respironics, Inc. | 2019 | — |
| +1 | K151901 | AirView | Resmed, Ltd. | 2015 | — |
| +1 | K261360 | EasyCare Tx 2 | Resmed Corp | 2026 | — |
| +1 | K251889 | myAir | Resmed Corp | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MNS? 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 MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 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 |
|---|---|---|---|
| * | K123557 | Easycare OnlineSummary page 3…Pins Eaaycre.Oni.ine (modified) Comments: 11rnmnN ,f ,--Seconidftry - predicate(K1 23557)j, predltie(K835511'- - ______ Intended EasyCare Online… | 2013 |
| * | K083575 | Apnealink Plus, Model: 22328Summary page 1…code 73 MNR) Predicate device(s) EasyCare Online (510(k) number (K(123557) ApneaL-ink Plus (510(k) number (K083575) Reason for submission Expanded Intended for Use. ResMed EGO T… | 2009 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 49 ancestors have a recall of any class.
- Of its descendants, K152356 (Respironics, Inc., 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
EasyCare Online 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 EasyCare Online compatible home sleep test device.
* transfer and display, usage and therapeutic information that has been transmitted remotely from the patient's therapy device located in the home. It is intended to support the standard follow-up care of patients that have been prescribed a compatible ResMed therapy device for the treatment of obstructive sleep apnea or respiratory insufficiency. EasyCare Online also provides remote settings capabilities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132371: Easycare Online.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132371
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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