Cleared Traditional

Spectrum IQ Infusion System with Dose IQ Safety Software

K220417 · Baxter Healthcare Corporation · General Hospital
Apr 2022
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K220417 is an FDA 510(k) clearance for the Spectrum IQ Infusion System with Dose IQ Safety Software, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on April 29, 2022, 74 days after receiving the submission on February 14, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K220417 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2022
Decision Date April 29, 2022
Days to Decision 74 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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