FDA 510(k) · Withings
K231667: Withings Sleep Rx (Withings)
Withings received FDA 510(k) K231667 for Withings Sleep Rx, with a decision date of Sep 6, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K231667 |
|---|---|
| Pathway | 510(k) |
| Applicant | Withings |
| Device name | Withings Sleep Rx |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Jun 7, 2023 |
| Decision date | Sep 6, 2024 |
| 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
Withings Sleep Rx is indicated to record a patient’s Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life- threatening situations.
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.