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LifeShield Infusion Safety Software Suite

by ICU Medical, Inc. 2 variants

510(k) K242117

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242117 Date2 Apr 2025ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0966-2026 FDA Class II initiated 24 Nov 2025

    Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

    • Ongoing Z-0965-2026 FDA Class II initiated 24 Nov 2025

    For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PHC
Device class
Class II
Regulation
21 CFR Part 880.5725
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LifeShield Infusion Safety Software Suite is an infusion safety management software designed to enhance the monitoring and administration of intravenous infusions in clinical settings. It integrates with infusion pumps to provide real-time alerts, dose verification, and compliance tracking to reduce medication errors and improve patient safety during infusion therapy. As classified under Infusion Safety Management Software, it supports workflow optimization and data-driven decision-making for healthcare providers.

This software is intended for use in General Hospital settings and operates as a Class II device under the Traditional 510(k) pathway, with FDA clearance (K242117). It is not a single-use or reusable medical device but rather a digital solution supplied as a software license, requiring compatible infusion pump integration. No sterility or MRI safety considerations apply, as it is a non-physical, software-based system. Storage and deployment depend on the healthcare facility’s IT infrastructure, adhering to manufacturer guidelines for optimal performance.

Other devices from ICU Medical, Inc.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LifeShield Infusion Safety Software Suite used for?

    The LifeShield Infusion Safety Software Suite is designed to enhance the safety and efficiency of intravenous infusion therapy in clinical settings. It integrates with infusion pumps to provide real-time alerts, dose verification, and compliance tracking. This helps healthcare providers minimize medication errors, streamline workflows, and make data-driven decisions to improve patient safety during infusion treatments.

  • How is the LifeShield Infusion Safety Software Suite supplied and does it require physical installation?

    The LifeShield Infusion Safety Software Suite is supplied as a software license, not as a physical device. It is a digital solution that requires integration with compatible infusion pumps. Deployment depends on the healthcare facility’s IT infrastructure, following the manufacturer’s guidelines for optimal performance.

  • Is the LifeShield Infusion Safety Software Suite single-use or reusable?

    Unlike traditional medical devices, the LifeShield Infusion Safety Software Suite is neither single-use nor reusable. It is a software-based system that operates continuously within a facility’s IT network, provided the necessary infrastructure and compatible infusion pumps are maintained.

  • Does the LifeShield Infusion Safety Software Suite have sterility or MRI safety considerations?

    No, sterility or MRI safety considerations do not apply to the LifeShield Infusion Safety Software Suite. As a non-physical, software-based system, it does not require sterilization or have compatibility concerns with MRI environments. Its functionality relies solely on digital integration with infusion pumps and IT infrastructure.

  • What types of infusion pumps is the LifeShield Infusion Safety Software Suite compatible with?

    The LifeShield Infusion Safety Software Suite is compatible with infusion pumps that support its integration requirements. The specific models and compatibility details are outlined in the manufacturer’s documentation, which includes a list of supported devices (e.g., ICU Medical’s own infusion pumps and others with compatible interfaces). Always verify compatibility with your facility’s existing equipment before deployment.