FDA 510(k) · VivaQuant (dba Rhythm Express)
K253148: RX-1 Sleep (Vivaquant, Inc. Dba Rhythm Express)
Vivaquant, Inc. Dba Rhythm Express received FDA 510(k) K253148 for RX-1 Sleep, with a decision date of Jun 22, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K253148 |
|---|---|
| Pathway | 510(k) |
| Applicant | Vivaquant, Inc. Dba Rhythm Express |
| Device name | RX-1 Sleep |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Sep 25, 2025 |
| Decision date | Jun 22, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Other. These are heuristics, not FDA fields.