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FDA 510(k)

LifeShield™ Infusion Safety Software Suite

K-Number: K223606 · 2023-08-24

ApplicantIcu Medical, Inc.
Decision Date2023-08-24
Product CodePHC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LifeShield™ Infusion Safety Software Suite is a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2023-08-24 under approval number K223606. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeShield™ Infusion Safety Software Suite?

LifeShield™ Infusion Safety Software Suite is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Icu Medical, Inc.. The 510(k) number is K223606.

When was LifeShield™ Infusion Safety Software Suite approved by the FDA?

LifeShield™ Infusion Safety Software Suite received FDA 510(k) clearance on 2023-08-24, under approval number K223606.

What company makes LifeShield™ Infusion Safety Software Suite?

LifeShield™ Infusion Safety Software Suite is manufactured by Icu Medical, Inc..

What is the FDA product code for LifeShield™ Infusion Safety Software Suite?

The FDA product code for LifeShield™ Infusion Safety Software Suite is PHC.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

Other Devices by Icu Medical, Inc.

K152006Cogent Hemodynamic Monitoring System K151969Hospira Extension Sets K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery System K170110Diana Medication Transfer Set K223607Plum Duo™ Infusion System K250616Clave™ Neutral-Displacement Needlefree Connectors

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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