# K040161: Sona Pillow

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Devices, Inc.
- Decided: Apr 30, 2004 after 98 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100160: Zzoma Positional Sleeper Model 001 (2010), 2 descendants of its own
- K140190: Night Shift (2014), 1 descendant of its own
- K180608: Lunoa System (2018), 0 descendants of its own

## Indications for use
MAY STOP OR DECREASE SNORING MAY BE UUSED TO TREAT MILD OBSTRUCTIVE SLLEEP APNEA MAY IMPROVE TTIT: QUALITY OF SLEEP

Source page: https://510kreport.com/device/K040161
Methodology: https://510kreport.com/methodology