Cleared Traditional

Dose IQ Safety Software

K230665 · Baxter Healthcare Corporation · General Hospital

Mar 2024

Decision

385d

Days

Class 2

Risk

About This 510(k) Submission

K230665 is an FDA 510(k) clearance for the Dose IQ Safety Software, a Infusion Safety Management Software (Class II — Special Controls, product code PHC), submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on March 29, 2024, 385 days after receiving the submission on March 10, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K230665 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2023
Decision Date	March 29, 2024
Days to Decision	385 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

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.