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) → PHC — Infusion Safety Management Software

# PHC · Infusion Safety Management Software

_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/PHC

## Overview

- **Product Code:** PHC
- **Device Name:** Infusion Safety Management Software
- **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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252130](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K252130.md) | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Apr 2, 2026 | SESE |
| [K243062](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K243062.md) | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson | Jun 20, 2025 | SESE |
| [K242117](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K242117.md) | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Apr 2, 2025 | SESE |
| [K230665](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K230665.md) | Dose IQ Safety Software | Baxter Healthcare Corporation | Mar 29, 2024 | SESE |
| [K223606](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K223606.md) | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | Aug 24, 2023 | SESE |
| [K211124](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K211124.md) | Dose IQ Safety Software | Baxter Healthcare Corporation | Aug 30, 2022 | SESE |
| [K210075](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K210075.md) | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | Mar 1, 2022 | SESE |
| [K182092](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K182092.md) | BD Intelliport System | Becton, Dickinson and Company | Apr 30, 2019 | SESE |
| [K141474](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K141474.md) | BECTON DICKINSON INTELLIPORT SYSTEM | Becton, Dickinson & CO | Dec 18, 2014 | SESE |
| [K141193](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PHC/K141193.md) | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 | Smiths Medical Asd, Inc. | Jul 25, 2014 | SESE |

## Top Applicants

- Icu Medical, Inc. — 3 clearances
- Baxter Healthcare Corporation — 2 clearances
- Becton Dickinson — 1 clearance
- Becton, Dickinson & CO — 1 clearance
- Becton, Dickinson and Company — 1 clearance

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

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