BiliWrap
FDA 510(k) K243372 · Gerium Medical, Ltd.
510(k) numberK243372
Submission
- Device name
- BiliWrap
- Applicant
- Gerium Medical, Ltd.
Yavne, IL - Received
- October 30, 2024
- Decision date
- May 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LBI – Unit, Neonatal Phototherapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5700
- Specialty
- General Hospital
Other 510(k)s with product code LBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)LBI · Traditional | Thera B Medical Products | 01/15/2026SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | Bistos Co., Ltd. | 05/28/2021SE |
| K200031 | Neonatal Phototherapy SystemLBI · Traditional | Avalon Biomedical (Shenzhen) Limited | 10/05/2020SE |
| K190899 | bili-hutLBI · Traditional | Little Sparrows Technologies, Inc. | 09/05/2019SE |
| K182178 | neoBLUE blanket LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/13/2018SE |
| K172656 | BiliLuxLBI · Traditional | Draeger Medical Systems, Inc. | 05/01/2018SE |
| K170585 | SkylifeLBI · Traditional | Neolight, LLC | 10/27/2017SE |
| K163526 | Bilicocoon Phototherapy SystemLBI · Traditional | Neomedlight | 10/06/2017SE |
| K160745 | neoBLUE compact LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/12/2016SE |
| K160238 | Airborne Phototherapy LightLBI · Abbreviated | International Biomedical | 06/14/2016SE |
Questions and answers
When was BiliWrap cleared by the FDA?
BiliWrap (K243372) received a 510(k) decision of Substantially Equivalent on May 29, 2025, 211 days after the submission was received.
What is the product code of K243372?
The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.