FDA Product Code LBI: Unit, Neonatal Phototherapy
Leading manufacturers include Draeger Medical Systems, Inc., Natus Medical Incorporated and Little Sparrows Technologies, Inc..
71
Total
71
Cleared
134d
Avg days
1976
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
237d
recently vs 131d historically
FDA 510(k) Cleared Unit, Neonatal Phototherapy Devices (Product Code LBI)
71 devices
Cleared
Jan 15, 2026
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
Thera B Medical Products
General Hospital
262d
Cleared
May 29, 2025
BiliWrap
Gerium Medical, Ltd.
General Hospital
211d
Cleared
May 28, 2021
Infant Phototherapy Equipment
Bistos Co., Ltd.
General Hospital
115d
Cleared
Oct 05, 2020
Neonatal Phototherapy System
Avalon Biomedical (Shenzhen) Limited
General Hospital
272d
Cleared
Sep 05, 2019
bili-hut
Little Sparrows Technologies, Inc.
General Hospital
150d
Cleared
Dec 13, 2018
neoBLUE blanket LED Phototherapy System
Natus Medical Incorporated
General Hospital
122d
Cleared
May 01, 2018
BiliLux
Draeger Medical Systems, Inc.
General Hospital
238d
Cleared
May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
Respironics, Inc.
General Hospital
6d
About Product Code LBI - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code LBI since 1976, with 71 receiving FDA clearance (average review time: 134 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LBI Product Code
Recent submissions under LBI have taken an average of 237 days to reach a decision - up from 131 days historically. Manufacturers should account for longer review timelines in current project planning.
LBI devices are reviewed by the General Hospital panel. Browse all General Hospital devices →