# K201439: Ventilator, Non-continuous (Respirator)

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Sep 25, 2020 after 116 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: 12 generations back to K971260 (1997). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181053: Care Orchestrator, Respironics, Inc. (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K201439
Methodology: https://510kreport.com/methodology