Submission Details
| 510(k) Number | K243372 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2024 |
| Decision Date | May 29, 2025 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
BiliWrap
May 2025
Decision
211d
Days
Class 2
Risk
About This 510(k) Submission
K243372 is an FDA 510(k) clearance for the BiliWrap, a Unit, Neonatal Phototherapy (Class II — Special Controls, product code LBI), submitted by Gerium Medical, Ltd. (Yavne, IL). The FDA issued a Cleared decision on May 29, 2025, 211 days after receiving the submission on October 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5700.
Device Classification
| Product Code | LBI — Unit, Neonatal Phototherapy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5700 |
Manufacturer
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