# K253553: Orion

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Jun 4, 2026 after 202 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: 8 generations back to K971260 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140054: Rescan, Resmed, Ltd. (2014) Summary page 5.

## Indications for use
Orion is a software platform intended to assist healthcare professionals in the management, and treatment of patients who have been diagnosed with sleep-disordered breathing by: • Displaying and analyzing device and therapeutic information that has been transmitted remotely from the patient’s compatible device to optimize patient care management and engagement. • Providing remote settings capabilities for compatible Resmed devices. • Communicating with digitally connected platforms.

Source page: https://510kreport.com/device/K253553
Methodology: https://510kreport.com/methodology