Cleared Traditional

LifeShield? Infusion Safety Software Suite

K223606 · Icu Medical, Inc. · General Hospital

Aug 2023

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K223606 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 August 24, 2023, 265 days after receiving the submission on December 2, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K223606 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2022
Decision Date	August 24, 2023
Days to Decision	265 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.