K251105 is an FDA 510(k) clearance for the Tetra (TM-20). This device is classified as a Immunoglobulin G (igg) Infusion System (Class II - Special Controls, product code PKP).
Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on December 22, 2025, 255 days after receiving the submission on April 11, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. An Immunoglobulin G (igg) Infusion System Is A Prescription Device Intended For Subcutaneous Delivery Of Immunoglobulin G (igg) In Accordance With The Fda Approved Labeling..
| 510(k) Number | K251105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2025 |
| Decision Date | December 22, 2025 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PKP - Immunoglobulin G (igg) Infusion System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | An Immunoglobulin G (igg) Infusion System Is A Prescription Device Intended For Subcutaneous Delivery Of Immunoglobulin G (igg) In Accordance With The Fda Approved Labeling. |