Cleared Traditional

Vigilant Software Suite ? Vigilant Master Med

K210075 · Fresenius Kabi AG · General Hospital

Mar 2022

Decision

413d

Days

Class 2

Risk

About This 510(k) Submission

K210075 is an FDA 510(k) clearance for the Vigilant Software Suite ? Vigilant Master Med, a Infusion Safety Management Software (Class II — Special Controls, product code PHC), submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on March 1, 2022, 413 days after receiving the submission on January 12, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K210075 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2021
Decision Date	March 01, 2022
Days to Decision	413 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PHC — Infusion Safety Management Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5725
Definition	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.