PHC · Infusion Safety Management Software
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | PHC |
|---|---|
| Device Name | Infusion Safety Management Software |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Apr 2, 2026 | SESE |
| K243062 | 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 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Apr 2, 2025 | SESE |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | Mar 29, 2024 | SESE |
| K223606 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | Aug 24, 2023 | SESE |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | Aug 30, 2022 | SESE |
| K210075 | Vigilant Software Suite Vigilant Master Med | Fresenius Kabi AG | Mar 1, 2022 | SESE |
| K182092 | BD Intelliport System | Becton, Dickinson and Company | Apr 30, 2019 | SESE |
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Becton, Dickinson & CO | Dec 18, 2014 | SESE |
| K141193 | 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
