LBI · Class II · 21 CFR 880.5700

FDA Product Code LBI: Unit, Neonatal Phototherapy

Leading manufacturers include Olympic Medical Corp., Air-Shields, Inc. and Ohmeda Medical.

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 Feb 17, 2012
NANOBLUTM 500
K113206
Draeger Medical Systems, Inc.
General Hospital · 108d
Cleared Jul 19, 2001
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549
Ohmeda Medical
General Hospital · 62d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627
Respironics, Inc.
General Hospital · 6d
Cleared Sep 24, 1997
DUO-LITE PHOTOTHERAPY SYSTEM
K971256
Air-Shields, Inc.
General Hospital · 173d
Cleared Sep 24, 1997
OLYMPIC BILI-BASSINET
K971601
Olympic Medical Corp.
General Hospital · 146d
Cleared Sep 16, 1994
OLYMPIC BILI-LITE
K940996
Olympic Medical Corp.
General Hospital · 196d
Cleared Jul 28, 1992
BILIBLANKET LIGHT METER
K910571
Ohmeda Medical
General Hospital · 533d
Cleared Oct 29, 1990
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
K903445
Olympic Medical Corp.
General Hospital · 90d
Cleared Aug 02, 1990
OLYMPIC MINI BILI-LITE, MODEL 77
K902749
Olympic Medical Corp.
General Hospital · 41d
Cleared Jul 16, 1990
OLYMPIC BILI-LITE-PAD(TM)
K901987
Olympic Medical Corp.
General Hospital · 75d
Cleared Sep 28, 1989
BILIBLANKET PHOTOTHERAPY DEVICE
K894129
Ohmeda Medical
General Hospital · 108d
Cleared Mar 23, 1984
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K840454
Air-Shields, Inc.
General Hospital · 60d
Cleared Dec 10, 1980
NEONATAL PHOTOTHERAPY UNIT
K802702
Ohio Medical Products
General Hospital · 37d
Cleared Sep 04, 1979
BILI-DOSIMETER
K791114
Olympic Medical Corp.
General Hospital · 81d
Cleared Oct 25, 1977
PHOTOTHERAPY/PROCEDURE LAMP
K771025
Cavitron Corp.
General Hospital · 139d
Cleared Nov 02, 1976
PHOTOTHERAPY LIGHT
K760872
Air-Shields, Inc.
General Hospital · 15d

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 →