Adapter SRA-1-01
Adapter SRA-1-01 is a body aspiration needle (FDA Class II; FDA product code KTI, Bronchoscope Accessory) made by Serpex Medical, Inc., cleared under FDA 510(k) K252874 on 8 Oct 2025 and listed in FDA GUDID since 8 Dec 2025 (UDI-DI 00860009430235), 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 | Number00860009430235 | Date8 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK252874 | Date8 Oct 2025 | StatusActive |
Official records
- AccessGUDID record 00860009430235
- FDA 510(k) database K252874
Across registries
- FDA 510(k) K252874 decided 8 Oct 2025 Active
- FDA GUDID UDI-DI 00860009430235 listed 8 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K252874
- Listed FDA GUDID 00860009430235
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Body aspiration needle, single-use
- Model / reference
- SRA-1-01
- Primary DI / UDI-DI
- 00860009430235
- 510(k) Number
- FDA product code
- KTI
- GMDN term
- Body aspiration needle, single-use
- Device class
- Class II
- Regulation number
- 874.4680
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code KTI (Bronchoscope Accessory).
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