PHC
- Product code
- PHC
- Device name
- Infusion Safety Management Software
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
FDA classification 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) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252130 | 2026-04-02 | Icu Medical, Inc. | LifeShield Infusion Safety Software Suite | |
| K243062 | 2025-06-20 | Becton Dickinson | BD Intelliport System; BD Intelliport Reader (516230… | |
| K242117 | 2025-04-02 | Icu Medical, Inc. | LifeShield Infusion Safety Software Suite | |
| K230665 | 2024-03-29 | Baxter Healthcare Corporation | Dose IQ Safety Software | FDA |
Official FDA classification page: PHC
Classification and pathway per current FDA publications. Data from openFDA (CC0).