Cleared Traditional

Novum IQ Large Volume Pump

K211122 · Baxter Healthcare Corporation · General Hospital
Mar 2024
Decision
1079d
Days
Class 2
Risk

About This 510(k) Submission

K211122 is an FDA 510(k) clearance for the Novum IQ Large Volume Pump, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on March 29, 2024, 1079 days after receiving the submission on April 15, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K211122 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2021
Decision Date March 29, 2024
Days to Decision 1079 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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