KIRO Set 100801
KIRO Set 100801 is a Class II device made by Kiro Grifols Sl., cleared under FDA 510(k) K152441 on 4 Dec 2015 and listed in FDA GUDID since 11 Nov 2016 (UDI-DI 08437014572100), active as of 23 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 | Number08437014572100 | Date11 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152441 | Date4 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 08437014572100
- FDA 510(k) database K152441
Across registries
- FDA 510(k) K152441 decided 4 Dec 2015 Active
- FDA GUDID UDI-DI 08437014572100 listed 11 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K152441
- Listed FDA GUDID 08437014572100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- KIRO Set
- Generic name
- Compounding transfer set
- Model / reference
- 100801
- Primary DI / UDI-DI
- 08437014572100
- 510(k) Number
- FDA product code
- LHI
- GMDN term
- Compounding transfer set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
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