Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725) → PKP — Immunoglobulin G (Igg) Infusion System

# PKP · Immunoglobulin G (Igg) Infusion System

_General Hospital · 21 CFR 880.5725 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP

## Overview

- **Product Code:** PKP
- **Device Name:** Immunoglobulin G (Igg) Infusion System
- **Regulation:** [21 CFR 880.5725](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5725)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K251105.md) | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | Dec 22, 2025 | SESE |
| [K240148](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K240148.md) | SCIg60 Infusion System | Emed Technologies Corporation | Feb 16, 2024 | SESE |
| [K230883](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K230883.md) | VersaPump Infusion System | Emed Technologies Corporation | Nov 28, 2023 | SESE |
| [K222087](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K222087.md) | SCIg60 Infusion System | Emed Technologies Corporation | Oct 13, 2022 | SESE |
| [K173783](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K173783.md) | SCIg60 Infusion System | Emed Technologies Corporation | Dec 14, 2018 | SESE |
| [K161906](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K161906.md) | SCIg60 Infuser | Emed Technologies Corporation | Dec 1, 2016 | SESE |
| [K142319](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP/K142319.md) | SCIg60 Infuser, Infuset | Emed Technologies Corporation | May 14, 2015 | SESE |

## Top Applicants

- Emed Technologies Corporation — 7 clearances

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PKP)

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