# K210075: Vigilant Software Suite – Vigilant Master Med

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Mar 1, 2022 after 413 days
- Product code: PHC (Infusion Safety Management Software)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904518 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
6 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121613: Agilia Infusion System, Fresenius Kabi AG (2013) Summary page 5.

## Indications for use
Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices. Vigilant Master Med is a drug library software that is used by pharmacists to create and identify limits according to policy and procedure of the institution. The infusion devices will notify and clearly indicate to a clinician if the dose for the medication is beyond the limits entered by the pharmacist and provided by Vigilant Master Med in the drug library.

Source page: https://510kreport.com/device/K210075
Methodology: https://510kreport.com/methodology