# K123411: Little Angels Swaddling Blanket

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: Mar 7, 2013 after 122 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: 1 generation back to K053568 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053568: Bilisoft Phototherapy System, Lumitex, Inc. (2006) Summary page 2.

## Most influential descendants
- K142416: Luma Wrap (2015), 0 descendants of its own

## Indications for use
The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. It is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K123411
Methodology: https://510kreport.com/methodology