Panels › General Hospital › Product code PHC · Class 2
Infusion Safety Management Software
Regulation 880.5725
1510(k)s in 12 months (10 all time)
2recalls in 12 months (13 all time)
12recalls that name a 510(k)
Top companies in PHC
| Company | 510(k)s | Recalls |
|---|---|---|
| Icu Medical, Inc. | 3 | 3 |
| Baxter Healthcare Corporation | 2 | 3 |
| Becton Dickinson | 2 | 1 |
| CareFusion 303, Inc. | 0 | 3 |
| Fresenius Kabi AG | 1 | 1 |
| Becton, Dickinson and Company | 1 | 0 |
| Fenwal Inc | 0 | 1 |
| Ivenix, Inc. | 0 | 1 |
| Smiths Medical Asd, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K252130 | LifeShield Infusion Safety Software Suite Icu Medical, Inc. | PHC |
| Jun 20, 2025 | K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); Becton Dickinson | PHC |
| Apr 2, 2025 | K242117 | LifeShield Infusion Safety Software Suite Icu Medical, Inc. | PHC |
| Mar 29, 2024 | K230665 | Dose IQ Safety Software Baxter Healthcare Corporation | PHC |
| Aug 24, 2023 | K223606 | LifeShield Infusion Safety Software Suite Icu Medical, Inc. | PHC |
| Aug 30, 2022 | K211124 | Dose IQ Safety Software Baxter Healthcare Corporation | PHC |
| Mar 1, 2022 | K210075 | Vigilant Software Suite Vigilant Master Med Fresenius Kabi AG, DE | PHC |
| Apr 30, 2019 | K182092 | BD Intelliport System Becton, Dickinson and Company | PHC |
| Dec 18, 2014 | K141474 | BECTON DICKINSON INTELLIPORT SYSTEM Becton, Dickinson & CO | PHC |
| Jul 25, 2014 | K141193 | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 Smiths Medical Asd, Inc. | PHC |
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