Belun Sleep System BLS-100 is an AI-enabled medical device from Belun Technology Company Limited that the U.S. FDA cleared through 510(k) K222579 on February 23, 2023. Its lead review panel is Anesthesiology and its primary product code is MNR (Ventilatory Effort Recorder).
See also FDA-cleared AI anesthesiology devices in 2023, all FDA AI clearances in 2023, top anesthesiology AI devices.
Key facts
| Submission number | K222579 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Belun Technology Company Limited |
| Lead review panel | Anesthesiology |
| Primary product code | MNR — Ventilatory Effort Recorder |
| Applicant (openFDA) | Belun Technology Company Limited |
| Applicant location | Sha Tin, CN |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.2375 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Belun Sleep System BLS-100 went through this pathway (K222579).
openFDA lists it as a Class 2 device under 21 CFR 868.2375. Class II devices are moderate risk and are subject to general and special controls.
Product code MNR covers 12 devices on the FDA AI list. By decision date, this device is #4 of 12 under that code. Belun Technology Company Limited has 1 AI-enabled device on the list, and the Anesthesiology panel accounts for 30 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.