PHC — Infusion Safety Management Software Class II
Classification Details
- Product Code
- PHC
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243062 | becton dickinson | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (51 | June 20, 2025 |
| K242117 | icu medical | LifeShield Infusion Safety Software Suite | April 2, 2025 |
| K230665 | baxter healthcare corporation | Dose IQ Safety Software | March 29, 2024 |
| K223606 | icu medical | LifeShield Infusion Safety Software Suite | August 24, 2023 |
| K211124 | baxter healthcare corporation | Dose IQ Safety Software | August 30, 2022 |
| K210075 | fresenius kabi | Vigilant Software Suite Vigilant Master Med | March 1, 2022 |
| K182092 | becton, dickinson and | BD Intelliport System | April 30, 2019 |
| K141474 | becton, dickinson and | BECTON DICKINSON INTELLIPORT SYSTEM | December 18, 2014 |
| K141193 | smiths medical asd | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSI | July 25, 2014 |