# LBI: Unit, Neonatal Phototherapy

- Device class: 2; regulation: 21 CFR 880.5700; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 163 days (middle half 139–187)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2015: 1
- 2016: 3
- 2017: 2
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K022196: Natus Blue Light Phototherapy Unit (2002), cited by 8
- K070180: Wallaby 4 (2007), cited by 4
- K113206: Nanoblutm 500 (2012), cited by 3
- K051869: Neoblue Cozy Led Phototherapy System (2005), cited by 3
- K103589: Neoblue Blanket Led Phototherapy System (2011), cited by 2
- K103828: Bili-Therapy Spot Type (2011), cited by 2
- K053568: Bilisoft Phototherapy System (2006), cited by 2
- K210289: Infant Phototherapy Equipment (2021), cited by 2
- K083179: Mediled Phototherapy Lamp (2009), cited by 2
- K974830: Ultra Bili Light (1998), cited by 2

Source page: https://510kreport.com/product-code/LBI
Data by year (CSV): https://510kreport.com/product-code/LBI.csv