Tetra Micro FP-0010215
by EMED Technologies Corporation
Tetra Micro FP-0010215 is a Class II device made by EMED Technologies Corporation, cleared under FDA 510(k) K251105 on 22 Dec 2025 and listed in FDA GUDID since 24 Feb 2026 (UDI-DI 00817708023374), 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 | Number00817708023374 | Date24 Feb 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK251105 | Date22 Dec 2025 | StatusActive |
Official records
- AccessGUDID record 00817708023374
- FDA 510(k) database K251105
Across registries
- FDA 510(k) K251105 decided 22 Dec 2025 Active
- FDA GUDID UDI-DI 00817708023374 listed 24 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K251105
- Listed FDA GUDID 00817708023374
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tetra Micro
- Generic name
- Bedside infusion pump, single-channel
- Model / Ref / Catalog
- FP-0010215
- Primary DI / UDI-DI
- 00817708023374
- 510(k) Number
- FDA product code
- PKP, FRN
- GMDN term
- Bedside infusion pump, single-channel
- Device class
- Class II
- Regulation number
- 880.5725
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FRN.
- MODIFIED PCA INFUSER by Bd Becton Dickinson Vacutainer Systems Preanalytic
- AVI MODEL 400D INFUSION PUMP by 3M Avi, Inc.
- MODEL 480CM INFUSION PUMP, MODIFICATION by 3M Health Care, Ltd.
- SYRINGE PUMP: VM 07 by Vial Medical, Ltd.
- PERSONAL MEDICATION INFUSER by Pacesetter Systems
- IVAC 3080 ENTERAL FEEDING PUMP by Y
- PLUM XL INFUSION PUMP (MODIFICATION) by Abbott Laboratories
- BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) by Belmont Instrument Corp.
- MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP by Medex, Inc.
- DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM by Disetronic Medical Systems