Infusion Safety Management Software
Infusion Safety Management Software is a prescription software device intended for use with infusion pumps, incorporating capabilities such as prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission to improve medication safety. It is an FDA Class 2 device regulated under 21 CFR 880.5725, requiring 510(k) premarket notification, within the General Hospital (HO) medical specialty. The product code is PHC. This device is not implantable and is not life-sustaining.
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Basic Information
- Product Code
- PHC
- Device Class
- FDA class 2
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Apr 02, 2026 | Substantially Equivalent | Icu Medical, Inc. |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Jun 20, 2025 | Substantially Equivalent | Becton Dickinson |
| K242117 | LifeShield Infusion Safety Software Suite | Apr 02, 2025 | Substantially Equivalent | Icu Medical, Inc. |
| K230665 | Dose IQ Safety Software | Mar 29, 2024 | Substantially Equivalent | Baxter Healthcare Corporation |
| K223606 | LifeShield Infusion Safety Software Suite | Aug 24, 2023 | Substantially Equivalent | Icu Medical, Inc. |
| K211124 | Dose IQ Safety Software | Aug 30, 2022 | Substantially Equivalent | Baxter Healthcare Corporation |
| K210075 | Vigilant Software Suite Vigilant Master Med | Mar 01, 2022 | Substantially Equivalent | Fresenius Kabi AG |
| K182092 | BD Intelliport System | Apr 30, 2019 | Substantially Equivalent | Becton, Dickinson and Company |
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Dec 18, 2014 | Substantially Equivalent | Becton, Dickinson & CO |
| K141193 | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 | Jul 25, 2014 | Substantially Equivalent | Smiths Medical Asd, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.