Cleared Traditional

Dose IQ Safety Software

K211124 · Baxter Healthcare Corporation · General Hospital

Aug 2022

Decision

502d

Days

Class 2

Risk

About This 510(k) Submission

K211124 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 August 30, 2022, 502 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	K211124 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2021
Decision Date	August 30, 2022
Days to Decision	502 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.