PHC — Infusion Safety Management Software Class II
FDA product code PHC covers "Infusion Safety Management Software", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252130 | icu medical | LifeShield Infusion Safety Software Suite | April 2, 2026 |
| 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 |