510(k) · Cleared
ClearedEasyCare Tx 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Corp · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on Aug 27, 2026 as substantially equivalent to K132371 (Resmed, Ltd., 2013) after a 125-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Aug 27, 2026
- Review
- 125 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971260 (1997). 50 ancestors in all, the oldest K914085 (1991). No later device cites it as a predicate yet.
- 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 deviceK261360 EasyCare Tx 2Resmed Corp · 2026
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 deviceK261360 EasyCare Tx 2Resmed Corp · 2026
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) | K261360 | EasyCare Tx 2 | 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 |
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 MOD? 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 MOD device
- #1 K253807 Valence InVent Xtend™ (CVG-4101-VXA)score 13.1 · 5 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.
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 29 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 50 ancestors have a recall of any class.
- 3 other devices also cite its predicate K132371.
How does its category compare?
All MOD devicesMOD Accessory To Continuous Ventilator (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MOD
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOD
125in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOD
1in 2022
MAUDE reports naming product code MOD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 125 | 1 | — |
What is it indicated for?
The EasyCare Tx 2 software is indicated for use by healthcare professionals in a clinical environment with compatible Resmed therapy devices via TxLink 2 to display real-time therapy data and treatment settings, and to provide therapy device setting changes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261360: EasyCare Tx 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261360
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026