Cleared Traditional

Spectrum IQ Infusion System with Dose IQ Safety Software

K222048 · Baxter Healthcare Corporation · General Hospital
Sep 2022
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K222048 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 September 6, 2022, 56 days after receiving the submission on July 12, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K222048 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2022
Decision Date September 06, 2022
Days to Decision 56 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

Similar Devices — FRN Pump, Infusion

All 847
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
K252015 · Koru Medical Systems, Inc. · Jan 2026
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · Baxter Healthcare Corporation · Jul 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · Baxter Healthcare Corporation · Jul 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · Carefusion 303, Inc. · Apr 2025
Plum Solo? Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025