PKP · Immunoglobulin G (Igg) Infusion System
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | PKP |
|---|---|
| Device Name | Immunoglobulin G (Igg) Infusion System |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | Dec 22, 2025 | SESE |
| K240148 | SCIg60 Infusion System | Emed Technologies Corporation | Feb 16, 2024 | SESE |
| K230883 | VersaPump Infusion System | Emed Technologies Corporation | Nov 28, 2023 | SESE |
| K222087 | SCIg60 Infusion System | Emed Technologies Corporation | Oct 13, 2022 | SESE |
| K173783 | SCIg60 Infusion System | Emed Technologies Corporation | Dec 14, 2018 | SESE |
| K161906 | SCIg60 Infuser | Emed Technologies Corporation | Dec 1, 2016 | SESE |
| K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | May 14, 2015 | SESE |
Top Applicants
- Emed Technologies Corporation — 7 clearances
