Olympic Bili-Lite Pad
Disposable Covers for Bili-Lite Pad
1manufacturer
1catalogue number
6510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Natus Medical Incorporated, United States |
|---|---|
| FDA product code | LBI |
| Device type | Unit, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-05-19 |
| Record revised | 2026-01-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Disposable Covers | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| bili-hut™ | Little Sparrows Technologies Inc | 33 |
| NeoBLUE blanket LED Phototherapy | Natus Medical Denmark ApS | 10 |
| neoBLUE | Natus Medical Incorporated | 9 |
| Bilisoft 2.0 | Lumitex, Inc. | 4 |
| BiliSoft Phototherapy System | Datex-Ohmeda, Inc. | 3 |
| Lamp | RPI | 3 |
| Giraffe Blue Spot PT Lite | Datex-Ohmeda, Inc. | 2 |
| BiliCocoon™ Nest System | Neomedlight | 2 |
| BiliCocoon™ Bag System | Neomedlight | 2 |
| BiliCocoon™ Nest Disposable | Neomedlight | 2 |
| Unit, Neonatal Phototherapy | Bistos Co., Ltd. | 2 |
| BiliCocoon™ Bag Pad | Neomedlight | 2 |
Showing 12 of 61. All products under Unit, Neonatal Phototherapy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182178 | 2018-12-13 |
| K160745 | 2016-12-12 |
| K160305 | 2016-05-27 |
| K103589 | 2011-05-13 |
| K051869 | 2005-10-07 |
| K022196 | 2002-09-19 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-03 | Class II | Component change control | The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall | 4,371 units (3,285 units in the US and 1,086 units outside o | 2019-08-13 |
| 2016-10-28 | Class II | Device Design | neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box. | 2619 units (1925 units in the US and 694 units OUTSIDE the U | 2021-01-15 |
| 2016-09-16 | Class II | Device Design | The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads e | 713 units total (403 units in US and 310 units outside US) | 2017-09-01 |
| 2016-04-11 | Class II | Labeling False and Misleading | The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device. | 13541 units total (7840 units in the US and 5701 units outsi | 2016-12-14 |
| 2015-08-05 | Class II | No Marketing Application | The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission. | 4560 units | 2016-03-17 |
| 2015-03-16 | Class II | Other | neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberopti | 2611 units (1911 units in the US and 700 units outside the U | 2016-12-20 |
| 2014-11-19 | Class II | Other | Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While s | 1907 total (1413 in US and 494 international) | 2015-07-20 |
| 2009-10-01 | Not classified | Device Design | The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported. | 2127 | 2011-09-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.