# K230883: VersaPump Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: Nov 28, 2023 after 243 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: 7 generations back to K831445 (1983). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222087: SCIg60 Infusion System, Emed Technologies Corporation (2022) Summary page 5.

## Indications for use
The VersaPump Infusion System is intended for the subcutaneous infusion of indicated fluids for patients in the home or hospital environment when administered by an adult according to the indicated fluid’s product labeling and with specified models of subcutaneous infusion sets, flow controllers, and syringes. The system is intended for single patient, multiple use only. The VersaPump Infusion System is indicated for adult and pediatric patients (2 years and older) that require subcutaneous infusion of fluid medication prescribed by a healthcare professional. The infusion system must be operated by an adult for use with pediatric patients. The VersaPump Infusion System is indicated for the subcutaneous infusion of: • Cuvitru Immune Globulin Infusion (Human) 20%, manufactured by Takeda, • Gammagard Liquid, Immune Globulin Infusion (Human) 10%, manufactured by Takeda, • Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring, • Gamunex-C Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics • Gammaked Immune Globulin Subcutaneous (Human) 10%, manufactured by Grifols Therapeutics • Xembify Immune Globulin Subcutaneous (Human) 20%, manufactured by Grifols Therapeutics, and • Cutaquig Immune Globulin (Human), 16.5%, manufactured by Octapharma AG.

Source page: https://510kreport.com/device/K230883
Methodology: https://510kreport.com/methodology