# K142416: Luma Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Jun 12, 2015 after 288 days
- Product code: PDH (Blanket, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K053568 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123411: Little Angels Swaddling Blanket, Bionix Development Corp. (2013) Summary page 4.

## Indications for use
To swaddle infants during neonatal phototherapy in the hospital or home setting. Single patient use only.

Source page: https://510kreport.com/device/K142416
Methodology: https://510kreport.com/methodology