# K180608: Lunoa System

- Pathway: 510(k) (Traditional)
- Applicant: Nightbalance BV
- Decided: Jun 5, 2018 after 90 days
- Product code: MYB (Pillow, Cervical (For Mild Sleep Apnea))
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K873535 (1987). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140190: Night Shift, Advanced Brain Monitoring, Inc. (2014) Summary page 4.

## Indications for use
The Lunoa System is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index <20. It records position and movement so that positional changes in sleep quality can be assessed.

Source page: https://510kreport.com/device/K180608
Methodology: https://510kreport.com/methodology