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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2025 | ICU Medical, Inc. LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2
Product No. 17003-02 Open, Classified |
PHC | K242117 |
| Dec 19, 2025 | ICU Medical, Inc. LifeShield Drug Library Management (DLM);
LifeShield Infusion Safety Software Suite v2.2
List Number 17003-02 Open, Classified |
PHC | K242117 |
| Jul 17, 2025 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Open, Classified |
PHC | K230022 |
| Jul 17, 2025 | Baxter Healthcare Corporation Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Open, Classified |
PHC | K133801 |
| May 14, 2025 | ICU Medical, Inc. LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 Open, Classified |
PHC | K223606 |
| Mar 13, 2025 | CareFusion 303, Inc. BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Open, Classified |
PHC | K211218 |
| Mar 13, 2025 | CareFusion 303, Inc. BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Open, Classified |
PHC | K211218 |
| Oct 6, 2022 | Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004
version 5.2.0 Terminated |
PHC | K183311 |
| Apr 22, 2022 | Ivenix, Inc. Ivenix Infusion System (IIS) Terminated |
PHC | K183311 |
| Aug 4, 2020 | CareFusion 303, Inc. BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate Open, Classified |
PHC | K133532 |
| Aug 12, 2019 | Fenwal Inc Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1
Product Usage:
Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion Terminated |
PHC | None listed |
| Sep 18, 2018 | Baxter Healthcare Corporation SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 Terminated |
PHC | K173084 |
| Mar 8, 2016 | Becton Dickinson & Company BD Intelliport Medication Management System Sensor
The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually adminis Terminated |
PHC | K141474 |
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