# K222579: Belun Sleep System BLS-100

- Pathway: 510(k) (Traditional)
- Applicant: Belun Technology Company Limited
- Decided: Feb 23, 2023 after 182 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: 11 generations back to K913396 (1992). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220028: NightOwl, Ectosense NV (2022) Summary page 4.

## Indications for use
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).

Source page: https://510kreport.com/device/K222579
Methodology: https://510kreport.com/methodology