FDA Product Code
FDA Product Code PHC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2026-04-02 | Traditional | PDF ↗ |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson | 2025-06-20 | Traditional | PDF ↗ |
| K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025-04-02 | Traditional | PDF ↗ |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2024-03-29 | Traditional | PDF ↗ |
| K223606 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2023-08-24 | Traditional | PDF ↗ |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-08-30 | Traditional | PDF ↗ |
| K210075 | Vigilant Software Suite Vigilant Master Med | Fresenius Kabi AG | 2022-03-01 | Traditional | PDF ↗ |
| K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019-04-30 | Traditional | PDF ↗ |
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Becton, Dickinson & CO | 2014-12-18 | Traditional | PDF ↗ |
| K141193 | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 | Smiths Medical Asd, Inc. | 2014-07-25 | Traditional | PDF ↗ |
Product code PHC · Class II · General Hospital. Data: openFDA.