FDA 510(k) · Belun
K222579: Belun Sleep System BLS-100 (Belun Technology Company Limited)
Belun Technology Company Limited received FDA 510(k) K222579 for Belun Sleep System BLS-100, with a decision date of Feb 23, 2023 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K222579 |
|---|---|
| Pathway | 510(k) |
| Applicant | Belun Technology Company Limited |
| Device name | Belun Sleep System BLS-100 |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Aug 25, 2022 |
| Decision date | Feb 23, 2023 |
| 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
The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
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.
Later records that cite K222579
- K242224 Happy Health Home Sleep Test (Happy Health, Jun 18, 2025, MNR)
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.