# K083874: Galaxy

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Jan 26, 2009 after 28 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061996: Sandman Pocket, Eb Neuro S.P.A. (2006) Summary page 1.

## Indications for use
The Galaxy is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Galaxy is intended for use in a supervised (hospital) or unsupervised (home) environment.

Source page: https://510kreport.com/device/K083874
Methodology: https://510kreport.com/methodology