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 Mar 14, 2013 as substantially equivalent to K093684 (Resmed, Ltd., 2010) and 1 other predicate after a 115-day review. Its family tree reaches back 8 generations to 1997. 9 later devices descend from it.
- Decided
- Mar 14, 2013
- Review
- 115 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K971260 (1997). 22 ancestors in all, the oldest K930656 (1994). 9 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 6 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 5 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 4 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK050775 ResscanResmed, Ltd. · 2005
- 2 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 1 generation backK093684 Easycare OnlineResmed, Ltd. · 2010
- This deviceK123557 Easycare OnlineResmed, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK152356 SapphireRespironics, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK181053 Care OrchestratorRespironics, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK151901 AirViewResmed, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK261360 EasyCare Tx 2Resmed Corp · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132371Easycare OnlineResmed, Ltd. · 2013 · cites it directly8descendants
- K152356SapphireRespironics, Inc. · 2016 · 2 generations on4descendants
- K181053Care OrchestratorRespironics, Inc. · 2019 · 3 generations on1descendant
- K151901AirViewResmed, Ltd. · 2015 · 2 generations on1descendant
- K261360EasyCare Tx 2Resmed Corp · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −7 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −6 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −5 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −4 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −2 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −1 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| 0 (this device) | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +1 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +2 | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| +3 | K181053 | Care Orchestrator | Respironics, Inc. | 2019 | — |
| +2 | K151901 | AirView | Resmed, Ltd. | 2015 | — |
| +2 | K261360 | EasyCare Tx 2 | Resmed Corp | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K093684 | Easycare OnlineSummary page 1…Ventilator, Continuous, Non-Life- Supporting (21 CER 868.5895, Product Code 73 MNS) Predicate devices EasyCare Online (K093684) ResScan (KI 13815) Reason for submission Indications for use have been expanded.… | 2010 |
| * | K113815 | ResscanSummary page 2…generators already supported by the predicate devices. The modified device is substantially equivalent to the predicate devices EasyCare Online (K093684) and ResScan (KI 113815) which includes compatibility with S9 AutoSet, cleared under K09 1947; VPAP III ST-A, cleared under K033276; and Stellar, cleared… | 2012 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132371 | Easycare Online | 2013 | 8 |
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 1.1 years on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K132371 (Resmed, Ltd., 2013) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K093684.
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 transfers and displays to clinicians, usage and therapeutic information that has been transmitted remotely from the patient's flow generator located in the home. EasyCare Online also provides remote settings capabilities.
EasyCare Online is intended to suppedt the standard follow-up care of patients that have been prescribed a compatible ResMed flow generator for the treatment of obstructive sleep apnea or respiratory insufficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123557: Easycare Online.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123557
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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