# K183226: Care Orchestrator Essence

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Oct 18, 2019 after 332 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K971260 (1997). 83 ancestors in all.
No later device cites it as a predicate yet.
3 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152356: Sapphire, Respironics, Inc. (2016) Summary page 4.
- K083526: Trilogy 100 Ventilator, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K183226
Methodology: https://510kreport.com/methodology