PHC
10 FDA 510(k) clearances · Product code
269 daysmedian time to decision
502 days90th percentile
10clearances measured
FDA profile
- Official device name
- Infusion Safety Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- FDA 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.
- Adverse events (MAUDE)
- 2021: 35 · 2025: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LifeShield Infusion Safety Software Suite (K252130) | Icu Medical, Inc. | 2026-04-02 |
| BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (K243062) | Becton Dickinson | 2025-06-20 |
| LifeShield Infusion Safety Software Suite (K242117) | Icu Medical, Inc. | 2025-04-02 |
| Dose IQ Safety Software (K230665) | Baxter Healthcare Corporation | 2024-03-29 |
| LifeShield™ Infusion Safety Software Suite (K223606) | Icu Medical, Inc. | 2023-08-24 |
| Dose IQ Safety Software (K211124) | Baxter Healthcare Corporation | 2022-08-30 |
| Vigilant Software Suite – Vigilant Master Med (K210075) | Fresenius Kabi AG | 2022-03-01 |
| BD Intelliport System (K182092) | Becton, Dickinson and Company | 2019-04-30 |
| BECTON DICKINSON INTELLIPORT SYSTEM (K141474) | Becton, Dickinson & CO | 2014-12-18 |
| MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 (K141193) | Smiths Medical Asd, Inc. | 2014-07-25 |
Track PHC automatically
Every clearance here is in the API, with alerts when new ones post.