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) → PMS — Peripheral Intravenous (Piv) Infiltration Monitor

# PMS · Peripheral Intravenous (Piv) Infiltration Monitor

_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/PMS

## Overview

- **Product Code:** PMS
- **Device Name:** Peripheral Intravenous (Piv) Infiltration Monitor
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233881](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PMS/K233881.md) | ivWatch® Model 400 | Ivwatch, LLC | Mar 15, 2024 | SESE |
| [K222212](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PMS/K222212.md) | ivWatch Model 400 | Ivwatch, LLC | Aug 24, 2022 | SESE |
| [K192385](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PMS/K192385.md) | ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable | Ivwatch, LLC | Jul 2, 2020 | SESE |
| [K162478](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PMS/K162478.md) | ivWatch | Ivwatch, LLC | Dec 22, 2016 | SESE |
| [K153605](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PMS/K153605.md) | ivWatch Model 400 | Ivwatch, LLC | Feb 11, 2016 | SESE |

## Top Applicants

- Ivwatch, LLC — 5 clearances

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

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