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) → QJY — Infusion Pump, Drug Specific, Pharmacy-Filled

# QJY · Infusion Pump, Drug Specific, Pharmacy-Filled

_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/QJY

## Overview

- **Product Code:** QJY
- **Device Name:** Infusion Pump, Drug Specific, Pharmacy-Filled
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243354](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY/K243354.md) | Remunity System | Deka Research & Development Corp. | Nov 27, 2024 | SESE |
| [K240256](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY/K240256.md) | Remunity System | Deka Research and Development | Jun 12, 2024 | SESE |
| [K202690](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY/K202690.md) | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | Dec 30, 2020 | SESE |
| [K191313](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QJY/K191313.md) | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | Feb 21, 2020 | SESE |

## Top Applicants

- Deka Research and Development — 2 clearances
- DEKA Research & Development — 1 clearance
- Deka Research & Development Corp. — 1 clearance

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

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