# K140190: Night Shift

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: May 29, 2014 after 125 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: 5 generations back to K873535 (1987). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100160: Zzoma Positional Sleeper Model 001, Sleep Specialists, LLC (2010) Summary page 3.
- K112514: Apnea Risk Evaluation System (Ares), Advanced Brain Monitoring, Inc. (2012) Summary page 3.

## Most influential descendants
- K180608: Lunoa System (2018), 0 descendants of its own

## Indications for use
The Night Shift is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index < 20, and to reduce or alleviate snoring. It records position, movement, and sound so that positional changes in sleep quality and snoring can be assessed.

Source page: https://510kreport.com/device/K140190
Methodology: https://510kreport.com/methodology