Vigilant Software Suite Vigilant Master Med
FDA 510(k) K210075 · Fresenius Kabi AG
510(k) numberK210075
Submission
- Device name
- Vigilant Software Suite Vigilant Master Med
- Applicant
- Fresenius Kabi AG
Bad Homburg, DE - Received
- January 12, 2021
- Decision date
- March 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHC – Infusion Safety Management Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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.
Other 510(k)s with product code PHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2026SE |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…PHC · Traditional | Becton Dickinson | 06/20/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 03/29/2024SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | Icu Medical, Inc. | 08/24/2023SE |
| K211124 | Dose IQ Safety SoftwarePHC · Traditional | Baxter Healthcare Corporation | 08/30/2022SE |
| K182092 | BD Intelliport SystemPHC · Traditional | Becton, Dickinson and Company | 04/30/2019SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | Becton, Dickinson & CO | 12/18/2014SE |
| K141193 | Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0PHC · Traditional | Smiths Medical Asd, Inc. | 07/25/2014SE |
More from Smiths Medical Asd, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | 01/09/2026SE |
| K221121 | Volumat Polyethylene I.V. Administration SetFPA · Traditional | 06/16/2023SE |
| K220301 | Volumat LineFPA · Traditional | 06/02/2023SE |
| K212445 | freeflex+ Transfer AdapterLHI · Traditional | 06/01/2022SE |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…FRN · Traditional | 03/01/2022SE |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…FRN · Traditional | 03/01/2022SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | 02/11/2021SE |
| K200530 | AMICUS Separator SystemGKT · Traditional | 09/11/2020SE |
| K192150 | AMICUS Separator SystemLKN · Traditional | 11/13/2019SE |
| K192368 | CATSmartCAC · Special | 09/27/2019SE |
Questions and answers
When was Vigilant Software Suite Vigilant Master Med cleared by the FDA?
Vigilant Software Suite Vigilant Master Med (K210075) received a 510(k) decision of Substantially Equivalent on March 1, 2022, 413 days after the submission was received.
What is the product code of K210075?
The FDA product code is PHC – Infusion Safety Management Software, a Class II (moderate risk) device regulated under 21 CFR 880.5725.