K210075 is an FDA 510(k) clearance for the Vigilant Software Suite – Vigilant Master Med. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5725. 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..
| 510(k) Number | K210075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |