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) → LZF — Pump, Infusion, Analytical Sampling

# LZF · Pump, Infusion, Analytical Sampling

_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/LZF

## Overview

- **Product Code:** LZF
- **Device Name:** Pump, Infusion, Analytical Sampling
- **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 |
| --- | --- | --- | --- | --- |
| [K192785](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K192785.md) | OptiScanner® 5000 Glucose Monitoring System | Optiscan Biomedical Corporation | Feb 5, 2020 | SESE |
| [K162042](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K162042.md) | OptiScanner 5000 Glucose Monitoring System | Optiscan Biomedical Corp. | Oct 16, 2017 | SESE |
| [K011238](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K011238.md) | RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM | Metracor Technologies, Inc. | Jan 8, 2002 | SESE |
| [K951739](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K951739.md) | PUMP/BLOOD CHEMISTRY MONITOR | Via Medical Corp. | Feb 28, 1996 | SESE |
| [K922997](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K922997.md) | VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. | Via Medical Corp. | Jan 11, 1994 | SEKD |
| [K920438](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K920438.md) | VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM | Via Medical Corp. | Oct 22, 1993 | SEKD |
| [K882830](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF/K882830.md) | INFUSION PUMP | Pemlab Corp. | Dec 30, 1988 | SESE |

## Top Applicants

- Via Medical Corp. — 3 clearances
- Metracor Technologies, Inc. — 1 clearance
- Optiscan Biomedical Corp. — 1 clearance
- Optiscan Biomedical Corporation — 1 clearance
- Pemlab 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/LZF](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LZF)

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