Panels › General Hospital › Product code LBI · Class 2
Unit, Neonatal Phototherapy
Regulation 880.5700
1510(k)s in 12 months (71 all time)
0recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in LBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Natus Medical Incorporated | 6 | 8 |
| Physician Engineered Products, Inc. | 6 | 1 |
| Olympic Medical Corp. | 6 | 0 |
| Ohmeda Medical | 3 | 1 |
| Air-Shields, Inc. | 3 | 0 |
| Draeger Medical Systems, Inc. | 2 | 1 |
| Lumitex, Inc. | 2 | 1 |
| Medix I.C.S.A. | 3 | 0 |
| Atom Medical Corporation | 2 | 0 |
| E & B Technologies, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2026 | K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) Thera B Medical Products | LBI |
| May 29, 2025 | K243372 | BiliWrap Gerium Medical, Ltd., IL | LBI |
| May 28, 2021 | K210289 | Infant Phototherapy Equipment Bistos Co., Ltd., KR | LBI |
| Oct 5, 2020 | K200031 | Neonatal Phototherapy System Avalon Biomedical (Shenzhen) Limited, CN | LBI |
| Sep 5, 2019 | K190899 | bili-hut Little Sparrows Technologies, Inc. | LBI |
| Dec 13, 2018 | K182178 | neoBLUE blanket LED Phototherapy System Natus Medical Incorporated | LBI |
| May 1, 2018 | K172656 | BiliLux Draeger Medical Systems, Inc. | LBI |
| Oct 27, 2017 | K170585 | Skylife Neolight, LLC | LBI |
| Oct 6, 2017 | K163526 | Bilicocoon Phototherapy System Neomedlight, FR | LBI |
| Dec 12, 2016 | K160745 | neoBLUE compact LED Phototherapy System Natus Medical Incorporated | LBI |
| Jun 14, 2016 | K160238 | Airborne Phototherapy Light International Biomedical | LBI |
| May 27, 2016 | K160305 | neoBLUE® LED Phototherapy System Natus Medical Incorporated | LBI |
| Mar 20, 2015 | K142332 | BT-400 Bio-Med USA | LBI |
| Feb 20, 2014 | K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 Fanem Lda | LBI |
| Jun 8, 2012 | K120820 | GIRAFFE BLUE SPOT PT LITE Lumitex, Inc. | LBI |
| May 2, 2012 | K120168 | LULLABY LED PHOTTHERAPY SYSTEM Wipro GE Healthcare Private, Ltd. | LBI |
| Apr 12, 2012 | K111547 | BILI-THERAPY PAD TYPE Atom Medical Corporation | LBI |
| Feb 17, 2012 | K113206 | NANOBLUTM 500 Draeger Medical Systems, Inc. | LBI |
| Feb 3, 2012 | K110550 | BRIGHT EMBRACE MODEL SBL60 Physician Engineered Products, Inc. | LBI |
| Aug 15, 2011 | K103735 | MEDILED MINI Medix I.C.S.A. | LBI |
| May 13, 2011 | K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM Natus Medical Incorporated | LBI |
| Mar 29, 2011 | K103828 | BILI-THERAPY SPOT TYPE Atom Medical Corporation | LBI |
| Apr 23, 2010 | K093618 | BILI-MIRROR MODEL BLM-1 Physician Engineered Products, Inc. | LBI |
| Apr 24, 2009 | K090192 | BILI BLUE F20T12/BBY AND F40T12/BBY Interlectric Corp. | LBI |
| Feb 27, 2009 | K083179 | MEDILED PHOTOTHERAPY LAMP Medix I.C.S.A. | LBI |
| Oct 30, 2007 | K072097 | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 Medical Select, Inc. | LBI |
| Aug 6, 2007 | K071828 | LULLABY Ge Healthcare Clinical Systems | LBI |
| May 18, 2007 | K070180 | WALLABY 4 Respironics Inc., Sleep & Home Respiratory Group | LBI |
| Apr 17, 2006 | K053568 | BILISOFT PHOTOTHERAPY SYSTEM Lumitex, Inc. | LBI |
| Oct 7, 2005 | K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM Natus Medical, Inc. | LBI |
| Jun 21, 2004 | K040853 | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 International Hospital Supply Co., NL | LBI |
| Sep 19, 2002 | K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT Natus Medical, Inc. | LBI |
| May 31, 2002 | K021531 | RPI REPLACEMENT PHOTOTHERAPY LIGHTS Replacement Parts Industries, Inc. | LBI |
| Jul 19, 2001 | K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM Ohmeda Medical | LBI |
| Mar 9, 2001 | K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT Medical Illumination International, Inc. | LBI |
| Sep 25, 2000 | K002414 | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE Fisher & Paykel Healthcare, Ltd., NZ | LBI |
| May 17, 1999 | K991627 | WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 Respironics, Inc. | LBI |
| Apr 20, 1999 | K984589 | PHOTOTHERAPY LAMP Medela, Inc. | LBI |
| May 20, 1998 | K974830 | ULTRA BILI LIGHT Physician Engineered Products, Inc. | LBI |
| Sep 24, 1997 | K971601 | OLYMPIC BILI-BASSINET Olympic Medical Corp. | LBI |
| Sep 24, 1997 | K971256 | DUO-LITE PHOTOTHERAPY SYSTEM Air-Shields, Inc. | LBI |
| Dec 12, 1996 | K962612 | BILIBED PHOTOTHERAPY LAMP Medela, Inc. | LBI |
| Dec 1, 1995 | K954611 | DRAGER PT4000 PHOTOTHERAPY SYSTEM Drager, Inc. | LBI |
| Sep 16, 1994 | K940996 | OLYMPIC BILI-LITE Olympic Medical Corp. | LBI |
| Jul 5, 1994 | K934946 | BILIBLANKET PLUS PHOTOTHERAPY SYSTEM Boc Health Care, Inc. | LBI |
| Dec 9, 1993 | K931965 | MEDIX PHOTOTHERAPY LAMP Medix I.C.S.A., AR | LBI |
| Jul 28, 1992 | K910571 | BILIBLANKET LIGHT METER Ohmeda Medical | LBI |
| Dec 13, 1991 | K912908 | AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM Air-Shields Vickers, Inc. | LBI |
| Oct 29, 1990 | K903445 | OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR Olympic Medical Corp. | LBI |
| Aug 2, 1990 | K902749 | OLYMPIC MINI BILI-LITE, MODEL 77 Olympic Medical Corp. | LBI |
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