510(k) Report

510(k) · Cleared

Cleared

Easycare Online

K132371510(k) TraditionalCleared Nov 22, 2013115-day reviewClass II21 CFR 868.5895

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2009: 2 other ancestors2012: 1 other ancestor2007: 2 other ancestors2004: 5 other ancestors2006: 2 other ancestors2003: 4 other ancestors2002: 5 other ancestors1998: 4 other ancestors2001: 2 other ancestors1999: 2 other ancestors1992: 4 other ancestors1991: 1 other ancestor1996: 3 other ancestors2005: 1 other ancestor1994: 1 other ancestor1995: 1 other ancestor2015: 1 descendant cleared2026: 2 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant clearedK971260 · Sullivan Humidaire Heated Humidifier · Resmed Corp · 1997K013909 · S7 Elite CP AP System · Resmed Corp · 2002K024191 · S7 Elite and Autoset Spirit Cpap Systems with Reslink · Resmed, Ltd. · 2003×2: 2 generations cleared close together, K033841 (2004), K041209 (2004) K050775 · Resscan · Resmed, Ltd. · 2005K082983 · Resscan-Pro · Resmed, Ltd. · 2009K093684 · Easycare Online · Resmed, Ltd. · 2010K123557 · Easycare Online · Resmed, Ltd. · 20131990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 9 other ancestors5 generations back: 7 other ancestors6 generations back: 7 other ancestors7 generations back: 5 other ancestors8 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K123557 · Easycare Online · Resmed, Ltd. · 2013K093684 · Easycare Online · Resmed, Ltd. · 2010K082983 · Resscan-Pro · Resmed, Ltd. · 2009K050775 · Resscan · Resmed, Ltd. · 2005K041209 · Resmed S8 Pioneer Cpap System · Resmed, Ltd. · 2004 · recalledK033841 · Resmed S8 Prime Cpap System · Resmed, Ltd. · 2004 · recalledK024191 · S7 Elite and Autoset Spirit Cpap Systems with Reslink · Resmed, Ltd. · 2003K013909 · S7 Elite CP AP System · Resmed Corp · 2002K971260 · Sullivan Humidaire Heated Humidifier · Resmed Corp · 1997−50
  1. Root · 9 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
  2. 5 generations between
  3. 3 generations backK082983 Resscan-ProResmed, Ltd. · 2009
  4. 2 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
  5. 1 generation backK123557 Easycare OnlineResmed, Ltd. · 2013
  6. This deviceK132371 Easycare OnlineResmed, Ltd. · 2013
  7. Descendant · cites it directly · 4 of its ownK152356 SapphireRespironics, Inc. · 2016
  8. Descendant · 2 generations on · 1 of its ownK181053 Care OrchestratorRespironics, Inc. · 2019
  9. Descendant · cites it directly · 1 of its ownK151901 AirViewResmed, Ltd. · 2015
  10. Descendant · cites it directly · 0 of its ownK261360 EasyCare Tx 2Resmed Corp · 2026
  11. Descendant · cites it directly · 0 of its ownK251889 myAirResmed Corp · 2026
Show all 9 generations
  1. Root · 9 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
  2. 8 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
  3. 7 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
  4. 6 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
  5. 5 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
  6. 4 generations backK050775 ResscanResmed, Ltd. · 2005
  7. 3 generations backK082983 Resscan-ProResmed, Ltd. · 2009
  8. 2 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
  9. 1 generation backK123557 Easycare OnlineResmed, Ltd. · 2013
  10. This deviceK132371 Easycare OnlineResmed, Ltd. · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12019: 22020: 12025: 12026: 2
2015high 2 (2019) · low 0 (2017)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−9K971260Sullivan Humidaire Heated HumidifierResmed Corp1997—
−8K013909S7 Elite CP AP SystemResmed Corp2002—
−7K024191S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd.2003—
−6K033841Resmed S8 Prime Cpap SystemResmed, Ltd.20041
−5K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd.20041
−4K050775ResscanResmed, Ltd.2005—
−3K082983Resscan-ProResmed, Ltd.2009—
−2K093684Easycare OnlineResmed, Ltd.2010—
−1K123557Easycare OnlineResmed, Ltd.2013—
0 (this device)K132371Easycare OnlineResmed, Ltd.2013—
+1K152356SapphireRespironics, Inc.2016—
+2K181053Care OrchestratorRespironics, Inc.2019—
+1K151901AirViewResmed, Ltd.2015—
+1K261360EasyCare Tx 2Resmed Corp2026—
+1K251889myAirResmed Corp2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199240
199410
199510
199630
199840
199920
200120
200250
200340
200450
200510
200620
200720
200920
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201920
202010
202510
202620
FIG. 1 — Lineage of K132371, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K123557Easycare Online
Summary page 3
…Pins Eaaycre.Oni.ine (modified) Comments: 11rnmnN ,f ,--Seconidftry - predicate(K1 23557)j, predltie(K835511'- - ______ Intended EasyCare Online…
Resmed, Ltd.2013—
*K083575Apnealink Plus, Model: 22328
Summary 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…
Resmed Germany, Inc.2009—

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152356SapphireRespironics, Inc.20164
K151901AirViewResmed, Ltd.20151
K261360EasyCare Tx 2Resmed Corp20260
K251889myAirResmed Corp20260

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 devices

MNS 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

2007: 42009: 42010: 42011: 32012: 52013: 32016: 22017: 12018: 12022: 12023: 12024: 12026 (partial year): 3
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNS

115in 2013

2007: 90 days median2009: 92 days median2010: 124 days median2011: 140 days median2012: 111 days median2013: 115 days median2026 (partial year): 269 days median
2007high 269 (2026) · low 90 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNS

1in 2008

2007: 22008: 12026 (partial year): 1, 1 Class I
2007high 2 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MNS

1,790in 2025

2007: 92008: 72009: 82010: 92011: 92012: 122013: 182014: 52015: 502016: 162017: 202018: 222019: 2752020: 642021: 2562022: 2,5142023: 1,3202024: 1,5712025: 1,790
2007high 2,514 (2022) · low 5 (2014)2025

MAUDE reports naming product code MNS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200749029
20080—17
200949208
2010412409
2011314009
20125111012
20133115018
20140—05
20150—050
20162—016
20171—020
20181—022
20190—0275
20200—064
20210—0256
20221—02,514
20231—01,320
20241—01,571
20250—01,790
202632691 (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.

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