510(k) · Cleared
ClearedVentilator, Non-continuous (Respirator)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 25, 2020 as substantially equivalent to K181053 (Respironics, Inc., 2019) after a 116-day review. Its family tree reaches back 12 generations to 1997.
- Decided
- Sep 25, 2020
- Review
- 116 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K971260 (1997). 53 ancestors in all, the oldest K914085 (1991). No later device cites it as a predicate yet.
- Root · 12 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 8 generations between
- 3 generations backK132371 Easycare OnlineResmed, Ltd. · 2013
- 2 generations backK152356 SapphireRespironics, Inc. · 2016
- 1 generation backK181053 Care OrchestratorRespironics, Inc. · 2019
- This deviceK201439 Ventilator, Non-continuous (Respirator)Respironics, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 11 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 10 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 9 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 8 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 7 generations backK050775 ResscanResmed, Ltd. · 2005
- 6 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 5 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 4 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 3 generations backK132371 Easycare OnlineResmed, Ltd. · 2013
- 2 generations backK152356 SapphireRespironics, Inc. · 2016
- 1 generation backK181053 Care OrchestratorRespironics, Inc. · 2019
- This deviceK201439 Ventilator, Non-continuous (Respirator)Respironics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −11 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −10 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −9 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −8 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −7 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −6 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −5 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| −4 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −3 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −2 | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| −1 | K181053 | Care Orchestrator | Respironics, Inc. | 2019 | — |
| 0 (this device) | K201439 | Ventilator, Non-continuous (Respirator) | Respironics, Inc. | 2020 | — |
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 |
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 BZD? 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 BZD device
- #1 K250624 myAirscore 15.7 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181053 | Care OrchestratorSummary page 5…Care Orchestrator with Home Sleep Testing Section 5 – 510(k) Summary III. Legally Marketed Predicate Device • Primary predicate: K181053, Care Orchestrator, Respironics Inc. The predicate has not been subject to any design-related recalls. • Reference device… | 2019 |
| † | K142988 | Sleepware G3 | 2015 |
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 23 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 53 ancestors have a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust…
Read the full statement (143 words)
Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. In addition, Care Orchestrator can be used for analysis (automatic and manual scoring), display, retrieval, summarization, and report generation of data received from compatible monitoring devices used to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The Home Sleep Testing function of Care Orchestrator is indicated for Adult use only. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201439 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201439: Ventilator, Non-continuous (Respirator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201439
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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