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) → LHF — Warmer, Microwave, Infusion Fluid

# LHF · Warmer, Microwave, Infusion Fluid

_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/LHF

## Overview

- **Product Code:** LHF
- **Device Name:** Warmer, Microwave, Infusion Fluid
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K811726](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHF/K811726.md) | LEKSELL STEREOACTIC SYSTEM | Downs Surgical , Ltd. | Jul 10, 1981 | SESE |
| [K811724](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHF/K811724.md) | 2M 9810 MICROWAVE OVEN | Travenol Laboratories, S.A. | Jul 10, 1981 | SESE |

## Top Applicants

- Downs Surgical , Ltd. — 1 clearance
- Travenol Laboratories, S.A. — 1 clearance

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

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