# K151050: Pacifier Activated Lullaby (PAL®)

- Pathway: 510(k) (Traditional)
- Applicant: Power Medical Devices, LLC
- Decided: Dec 22, 2015 after 246 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010388 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010388: Sondrex P.a.L. System, Ohmeda Medical (2001) Summary page 4.

## Recalls of this device
- Oct 1, 2015 · Class II · Z-0395-2016: PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).

## Indications for use
The Pacifier Activated Lullaby (PAL®) encourages and reinforces effective non-nutritive sucking of premature infants. This is accomplished by giving positive feedback to the infant in the form of music or a mother's voice as auditory input in direct response to sucking.

Source page: https://510kreport.com/device/K151050
Methodology: https://510kreport.com/methodology