510(k) K223606

LifeShield Infusion Safety Software Suite by Icu Medical, Inc. — Product Code PHC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 24, 2023
Date Received: December 2, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Infusion Safety Management Software
Device Class: Class II
Regulation Number: 880.5725
Review Panel: HO
Submission Type

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.

Other clearances by Icu Medical, Inc.

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K242114 — Plum Solo Precision IV Pump (April 2, 2025)
K243985 — Rio Drug Reconstitution Transfer Device (January 22, 2025)
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS (December 20, 2023)
K223607 — Plum Duo Infusion System (August 24, 2023)
K192154 — Rio Vial-to-Bag Drug Reconstitution Device (April 20, 2020)
K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
K190157 — Diana ChemoClave Transfer Set (October 23, 2019)

Other clearances for product code PHC

K243062 — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (51 (June 20, 2025)
K242117 — LifeShield Infusion Safety Software Suite (April 2, 2025)
K230665 — Dose IQ Safety Software (March 29, 2024)
K211124 — Dose IQ Safety Software (August 30, 2022)
K210075 — Vigilant Software Suite Vigilant Master Med (March 1, 2022)
K182092 — BD Intelliport System (April 30, 2019)
K141474 — BECTON DICKINSON INTELLIPORT SYSTEM (December 18, 2014)
K141193 — MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSI (July 25, 2014)