Kernel KN-5000H
by Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel KN-5000H is a Class II device made by Xuzhou Kernel Medical Equipment Co., Ltd., cleared under FDA 510(k) K242977 on 6 Feb 2025 and listed in FDA GUDID since 11 Mar 2025 (UDI-DI 06928798600421), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06928798600421 | Date11 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242977 | Date6 Feb 2025 | StatusActive |
Official records
- AccessGUDID record 06928798600421
- FDA 510(k) database K242977
Across registries
- FDA 510(k) K242977 decided 6 Feb 2025 Active
- FDA GUDID UDI-DI 06928798600421 listed 11 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K242977
- Listed FDA GUDID 06928798600421
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kernel
- Generic name
- Ultraviolet phototherapy unit, home-use
- Model / reference
- KN-5000H
- Primary DI / UDI-DI
- 06928798600421
- 510(k) Number
- FDA product code
- FTC
- GMDN term
- Ultraviolet phototherapy unit, home-use
- Device class
- Class II
- Regulation number
- 878.4630
- GUDID distribution status
- In Commercial Distribution
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