Cleared Traditional

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

K210074 · Fresenius Kabi AG · General Hospital
Mar 2022
Decision
413d
Days
Class 2
Risk

About This 510(k) Submission

K210074 is an FDA 510(k) clearance for the Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable, a Pump, Infusion (Class II — Special Controls, product code FRN), 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 K210074 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 FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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