# K242117: LifeShield Infusion Safety Software Suite

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Apr 2, 2025 after 257 days
- Product code: PHC (Infusion Safety Management Software)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904518 (1990). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223606: LifeShield™ Infusion Safety Software Suite, Icu Medical, Inc. (2023) Summary page 5.

## Most influential descendants
- K252130: LifeShield Infusion Safety Software Suite (2026), 0 descendants of its own

## Recalls of this device
- Nov 24, 2025 · Class II · Z-0965-2026: 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 change
- Nov 24, 2025 · Class II · Z-0966-2026: 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 

## Indications for use
The LifeShield™ Infusion Safety Software Suite is a collection of software products that facilitates networked communication between compatible systems. The Infusion Safety Software Suite provides trained healthcare professionals the ability to manage data for compatible infusion pumps. All data entry and validation of infusion parameters on compatible infusion pumps is performed by a trained healthcare professional. LifeShield™ Infusion Safety Software Suite is indicated for use in patients including adult, pediatric and neonate undergoing infusion therapy with connected compatible infusion pumps (as per the indications for use specified for the compatible infusion pump). The LifeShield™ Drug Library Management (DLM) software product is intended to be used by pharmacists to create, configure, edit, and manage drug library data, including infusion pump settings, for use with compatible infusion pumps. Drug library contents are constructed based on the healthcare provider's defined best practices. The LifeShield™ Clinical Dashboards & Reports (CDR) software product provides trained healthcare professionals with the capability to view and manage infusion information collected from compatible infusion pumps. Healthcare professionals may choose to use the collected infusion information to support continuous quality improvement programs, or to analyze and trend various aspects of the infusion pumps and therapies used. It is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways. The LifeShield™ Data Flow Management (DFM) software product is intended to facilitate bi-directional communication with compatible infusion pumps, information technology systems, and other LifeShield™ Infusion Safety Software Suite products. LifeShield™ DFM provides a way to automate the programming of infusion parameters, thereby decreasing the number of manual steps necessary to enter infusion data. LifeShield™ DFM forwards infusion-related information received from the infusion pump to compatible information technology systems.

Source page: https://510kreport.com/device/K242117
Methodology: https://510kreport.com/methodology