LBI · Class II · 21 CFR 880.5700

FDA Product Code LBI: Unit, Neonatal Phototherapy

Leading manufacturers include Olympic Medical Corp., Natus Medical Incorporated and Air-Shields, 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
1–24 of 71
Cleared Jan 15, 2026
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308
Thera B Medical Products
General Hospital · 262d
Cleared May 29, 2025
BiliWrap
K243372
Gerium Medical, Ltd.
General Hospital · 211d
Cleared May 28, 2021
Infant Phototherapy Equipment
K210289
Bistos Co., Ltd.
General Hospital · 115d
Cleared Oct 05, 2020
Neonatal Phototherapy System
K200031
Avalon Biomedical (Shenzhen) Limited
General Hospital · 272d
Cleared Sep 05, 2019
bili-hut
K190899
Little Sparrows Technologies, Inc.
General Hospital · 150d
Cleared Dec 13, 2018
neoBLUE blanket LED Phototherapy System
K182178
Natus Medical Incorporated
General Hospital · 122d
Cleared May 01, 2018
BiliLux
K172656
Draeger Medical Systems, Inc.
General Hospital · 238d
Cleared Oct 27, 2017
Skylife
K170585
Neolight, LLC
General Hospital · 241d
Cleared Oct 06, 2017
Bilicocoon™ Phototherapy System
K163526
Neomedlight
General Hospital · 294d
Cleared Dec 12, 2016
neoBLUE compact LED Phototherapy System
K160745
Natus Medical Incorporated
General Hospital · 269d
Cleared Jun 14, 2016
Airborne Phototherapy Light
K160238
International Biomedical
General Hospital · 134d
Cleared May 27, 2016
neoBLUE® LED Phototherapy System
K160305
Natus Medical Incorporated
General Hospital · 113d
Cleared Mar 20, 2015
BT-400
K142332
Bio-Med USA
General Hospital · 212d
Cleared Feb 20, 2014
INFANT PHOTOTHERAPY BILITRON SKY 5006
K131196
Fanem Lda
General Hospital · 300d
Cleared Jun 08, 2012
GIRAFFE BLUE SPOT PT LITE
K120820
Lumitex, Inc.
General Hospital · 81d
Cleared May 02, 2012
LULLABY LED PHOTTHERAPY SYSTEM
K120168
Wipro GE Healthcare Private, Ltd.
General Hospital · 104d
Cleared Apr 12, 2012
BILI-THERAPY PAD TYPE
K111547
Atom Medical Corporation
General Hospital · 314d
Cleared Feb 17, 2012
NANOBLUTM 500
K113206
Draeger Medical Systems, Inc.
General Hospital · 108d
Cleared Feb 03, 2012
BRIGHT EMBRACE MODEL SBL60
K110550
Physician Engineered Products, Inc.
General Hospital · 343d
Cleared Aug 15, 2011
MEDILED MINI
K103735
Medix I.C.S.A.
General Hospital · 236d
Cleared May 13, 2011
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
K103589
Natus Medical Incorporated
General Hospital · 157d
Cleared Mar 29, 2011
BILI-THERAPY SPOT TYPE
K103828
Atom Medical Corporation
General Hospital · 91d
Cleared Apr 23, 2010
BILI-MIRROR MODEL BLM-1
K093618
Physician Engineered Products, Inc.
General Hospital · 151d
Cleared Apr 24, 2009
BILI BLUE F20T12/BBY AND F40T12/BBY
K090192
Interlectric Corp.
General Hospital · 87d

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 →