Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LBI — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
262 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | 2026-01-15 | 262 | 0 |
| K243372 | BiliWrap | Gerium Medical, Ltd. | 2025-05-29 | 211 | 0 |
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021-05-28 | 115 | 0 |
| K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 | 272 | 0 |
| K190899 | bili-hut | Little Sparrows Technologies, Inc. | 2019-09-05 | 150 | 0 |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | 2018-12-13 | 122 | 0 |
| K172656 | BiliLux | Draeger Medical Systems, Inc. | 2018-05-01 | 238 | 0 |
| K170585 | Skylife | Neolight, LLC | 2017-10-27 | 241 | 0 |
| K163526 | Bilicocoon™ Phototherapy System | Neomedlight | 2017-10-06 | 294 | 0 |
| K160745 | neoBLUE compact LED Phototherapy System | Natus Medical Incorporated | 2016-12-12 | 269 | 0 |
| K160238 | Airborne Phototherapy Light | International Biomedical | 2016-06-14 | 134 | 0 |
| K160305 | neoBLUE® LED Phototherapy System | Natus Medical Incorporated | 2016-05-27 | 113 | 0 |
| K142332 | BT-400 | Bio-Med USA | 2015-03-20 | 212 | 0 |
| K131196 | INFANT PHOTOTHERAPY BILITRON SKY 5006 | Fanem Lda | 2014-02-20 | 300 | 0 |
| K120820 | GIRAFFE BLUE SPOT PT LITE | Lumitex, Inc. | 2012-06-08 | 81 | 0 |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2012-05-02 | 104 | 0 |
| K111547 | BILI-THERAPY PAD TYPE | Atom Medical Corporation | 2012-04-12 | 314 | 0 |
| K113206 | NANOBLUTM 500 | Draeger Medical Systems, Inc. | 2012-02-17 | 108 | 0 |
| K110550 | BRIGHT EMBRACE MODEL SBL60 | Physician Engineered Products, Inc. | 2012-02-03 | 343 | 1 |
| K103735 | MEDILED MINI | Medix I.C.S.A. | 2011-08-15 | 236 | 0 |
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | Natus Medical Incorporated | 2011-05-13 | 157 | 2 |
| K103828 | BILI-THERAPY SPOT TYPE | Atom Medical Corporation | 2011-03-29 | 91 | 0 |
| K093618 | BILI-MIRROR MODEL BLM-1 | Physician Engineered Products, Inc. | 2010-04-23 | 151 | 0 |
| K090192 | BILI BLUE F20T12/BBY AND F40T12/BBY | Interlectric Corp. | 2009-04-24 | 87 | 0 |
| K083179 | MEDILED PHOTOTHERAPY LAMP | Medix I.C.S.A. | 2009-02-27 | 122 | 0 |
| K072097 | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 | Medical Select, Inc. | 2007-10-30 | 91 | 0 |
| K071828 | LULLABY | Ge Healthcare Clinical Systems | 2007-08-06 | 34 | 0 |
| K070180 | WALLABY 4 | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-18 | 119 | 0 |
| K053568 | BILISOFT PHOTOTHERAPY SYSTEM | Lumitex, Inc. | 2006-04-17 | 116 | 0 |
| K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | Natus Medical, Inc. | 2005-10-07 | 88 | 0 |
| K040853 | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 | International Hospital Supply Co. | 2004-06-21 | 81 | 0 |
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | Natus Medical, Inc. | 2002-09-19 | 76 | 4 |
| K021531 | RPI REPLACEMENT PHOTOTHERAPY LIGHTS | Replacement Parts Industries, Inc. | 2002-05-31 | 21 | 0 |
| K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM | Ohmeda Medical | 2001-07-19 | 62 | 0 |
| K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT | Medical Illumination International, Inc. | 2001-03-09 | 17 | 0 |
| K002414 | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW | Fisher & Paykel Healthcare, Ltd. | 2000-09-25 | 49 | 0 |
| K991627 | WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 | Respironics, Inc. | 1999-05-17 | 6 | 0 |
| K984589 | PHOTOTHERAPY LAMP | Medela, Inc. | 1999-04-20 | 117 | 0 |
| K974830 | ULTRA BILI LIGHT | Physician Engineered Products, Inc. | 1998-05-20 | 147 | 0 |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | Air-Shields, Inc. | 1997-09-24 | 173 | 0 |
| K971601 | OLYMPIC BILI-BASSINET | Olympic Medical Corp. | 1997-09-24 | 146 | 0 |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Medela, Inc. | 1996-12-12 | 162 | 0 |
| K954611 | DRAGER PT4000 PHOTOTHERAPY SYSTEM | Drager, Inc. | 1995-12-01 | 58 | 1 |
| K940996 | OLYMPIC BILI-LITE | Olympic Medical Corp. | 1994-09-16 | 196 | 0 |
| K934946 | BILIBLANKET PLUS PHOTOTHERAPY SYSTEM | Boc Health Care, Inc. | 1994-07-05 | 260 | 0 |
| K931965 | MEDIX PHOTOTHERAPY LAMP | Medix I.C.S.A. | 1993-12-09 | 231 | 0 |
| K910571 | BILIBLANKET LIGHT METER | Ohmeda Medical | 1992-07-28 | 533 | 0 |
| K912908 | AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM | Air-Shields Vickers, Inc. | 1991-12-13 | 164 | 0 |
| K903445 | OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR | Olympic Medical Corp. | 1990-10-29 | 90 | 0 |
| K902749 | OLYMPIC MINI BILI-LITE, MODEL 77 | Olympic Medical Corp. | 1990-08-02 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda