Cleared Traditional

LifeShield Infusion Safety Software Suite

K242117 · Icu Medical, Inc. · General Hospital

Apr 2025

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K242117 is an FDA 510(k) clearance for the LifeShield Infusion Safety Software Suite, a Infusion Safety Management Software (Class II — Special Controls, product code PHC), submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 2, 2025, 257 days after receiving the submission on July 19, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K242117 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2024
Decision Date	April 02, 2025
Days to Decision	257 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.