# K253148: RX-1 Sleep

- Pathway: 510(k) (Traditional)
- Applicant: Vivaquant, Inc. Dba Rhythm Express
- Decided: Jun 22, 2026 after 270 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: 13 generations back to K913396 (1992). 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)
- K244027: Sansa Hsat, Huxley Medical (2025) Summary page 5.

## Indications for use
RX-1 Sleep is a Software as a Medical Device (SaMD) to aid in the evaluation of sleep-related breathing disorders in adults suspected of having sleep apnea. RX-1 Sleep is a cloud-based algorithm that analyzes inputs provided by two FDA cleared devices intended for clinical and home use: a) the Rhythm Express RX-1 mini and b) a Viatom pulse oximeter. Biophysical parameters provided by RX-1 Sleep are recorded and stored for presentation to a Healthcare Professional (HCP). RX-1 Sleep is intended for use under the direction of a Healthcare Professional.

Source page: https://510kreport.com/device/K253148
Methodology: https://510kreport.com/methodology