510(k) · Cleared
ClearedCare Orchestrator Essence
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 Oct 18, 2019 as substantially equivalent to K152356 (Respironics, Inc., 2016) and 1 other predicate after a 332-day review. Its family tree reaches back 11 generations to 1997. 3 of the 84 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 18, 2019
- Review
- 332 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K971260 (1997). 83 ancestors in all, the oldest K841279 (1984). No later device cites it as a predicate yet. 3 of the 84 devices in this family, counting this one, have a Class I recall.
- 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 backK152356 SapphireRespironics, Inc. · 2016
- This deviceK183226 Care Orchestrator EssenceRespironics, Inc. · 2019
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 backK152356 SapphireRespironics, Inc. · 2016
- This deviceK183226 Care Orchestrator EssenceRespironics, Inc. · 2019
Class I recalls in this family
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 | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| 0 (this device) | K183226 | Care Orchestrator Essence | Respironics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 1 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 1 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 3 | 1 |
| 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.
3 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K152356 | SapphireSummary page 4…nuous ventilator (21 CFR 868.5895, Product Codes MNS, MNT, CBK, NOU) III. Legally Marketed Predicate Device Predicate: K152356 Sapphire, Respironics Inc. Trade Name: Care Orchestrator Reference: K083526 Trilogy/DirectView, Respironics Inc.… | 2016 |
| * | K083526 | Trilogy 100 VentilatorSummary page 4…CBK, NOU) III. Legally Marketed Predicate Device Predicate: K152356 Sapphire, Respironics Inc. Trade Name: Care Orchestrator Reference: K083526 Trilogy/DirectView, Respironics Inc. Trade Name: Trilogy 100 Ventilator (DirectView) Respironics Inc.… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 83 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K152356.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Essence is intended for use by healthcare professionals (e.g., Physicians, Clinicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to…
Read the full statement (136 words)
Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Clinicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics’ non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives.
The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183226: Care Orchestrator Essence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183226
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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