510(k) · Cleared
ClearedEveryWare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breas Medical AB · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on May 20, 2025 as substantially equivalent to K151901 (Resmed, Ltd., 2015) and 1 other predicate after a 272-day review. Its family tree reaches back 11 generations to 1997.
- Decided
- May 20, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K971260 (1997). 53 ancestors in all, the oldest K914085 (1991). No later device cites it as a predicate yet.
- Root · 11 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations between
- 3 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 2 generations backK132371 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK151901 AirViewResmed, Ltd. · 2015
- This deviceK242485 EveryWareBreas Medical AB · 2025
Show all 11 generations
- Root · 11 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 10 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 9 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 8 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 7 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK050775 ResscanResmed, Ltd. · 2005
- 5 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 4 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 3 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 2 generations backK132371 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK151901 AirViewResmed, Ltd. · 2015
- This deviceK242485 EveryWareBreas Medical AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −10 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −9 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −8 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −7 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −5 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −4 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| −3 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −2 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −1 | K151901 | AirView | Resmed, Ltd. | 2015 | — |
| 0 (this device) | 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 |
| 2016 | 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 K261360 EasyCare Tx 2score 14.6 · 10 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 |
|---|---|---|---|
| * | K151901 | AirViewSummary page 5…o) Continuous Ventilator Classification Name Regulation: 21 C.F.R. §868.5895 Continuous Ventilator, Class II Primary Predicate Device(s) ResMed Ltd. AirView cleared in K151901 Secondary Predicate Device(s) Respironics Inc. Care Orchestrator (Sapphire) cleared in K152356 Device Description EveryWare is… | 2015 |
| * | K152356 | SapphireSummary page 5…tor, Class II Primary Predicate Device(s) ResMed Ltd. AirView cleared in K151901 Secondary Predicate Device(s) Respironics Inc. Care Orchestrator (Sapphire) cleared in K152356 Device Description EveryWare is a platform that gathers treatment information from Breas respiratory devices in a secure cloud-… | 2016 |
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 28 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 53 ancestors have a recall of any class.
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. 2025, 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?
EveryWare is indicated to support clinicians by managing data of patients who are prescribed
compatible therapy devices in accordance with the intended use of those therapy devices.
EveryWare provides remote patient data collection & viewing and is intended to be used by
healthcare representatives in conjunction with compatible non-life support therapy devices to adjust
prescription and/or performance settings. EveryWare is intended to be used in hospital, institutional,
provider, and home care settings.
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/K242485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242485: EveryWare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242485
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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