# K113206: Nanoblutm 500

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Feb 17, 2012 after 108 days
- Product code: LBI (Unit, 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 K940996 (1994). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022196: Natus Blue Light Phototherapy Unit, Natus Medical, Inc. (2002) Summary page 2.

## Most influential descendants
- K172656: BiliLux (2018), 0 descendants of its own
- K160238: Airborne Phototherapy Light (2016), 0 descendants of its own
- K131196: Infant Phototherapy Bilitron Sky 5006 (2014), 0 descendants of its own

## Indications for use
The Dräger NanoBlu 500 LED Phototherapy Light is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.

Source page: https://510kreport.com/device/K113206
Methodology: https://510kreport.com/methodology