# K251105: Tetra (TM-20); Tetra (TM-50)

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: Dec 22, 2025 after 255 days
- Product code: PKP (Immunoglobulin G (Igg) Infusion System)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K831445 (1983). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240148: SCIg60 Infusion System, Emed Technologies Corporation (2024) Summary page 5.
- K091042: Crono S-Pid 50, Cane S.R.L. (2009) Summary page 5.

## Indications for use
The EMED Tetra Micro Infusion System is intended for subcutaneous infusion for prescription liquid medicines for use in the home and hospital environment by adults and children (2 years and older), when administered according to the approved biologic or drug product labeling. The Tetra Micro Infusion System is indicated for use with: - Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring.

Source page: https://510kreport.com/device/K251105
Methodology: https://510kreport.com/methodology