LifeShield Infusion Safety Software Suite
by ICU Medical, Inc. 2 variants
510(k) K252130
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252130 | Date2 Apr 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
The LifeShield Infusion Safety Software Suite is an infusion safety management software designed to enhance the monitoring and administration of intravenous infusions in hospital settings. It integrates with infusion pumps to provide real-time safety alerts, dose verification, and compliance tracking, helping to prevent medication errors and improve patient safety during infusion therapy.
This software is intended for use in general hospital environments and is supplied as a digital solution compatible with ICU Medical’s Plum Duo and Plum Solo infusion pumps. It operates as a reusable, non-sterile Class II device under FDA 510(k) clearance (K252130) via the Traditional pathway, with product code PHC. No specific sterility or single-use requirements apply, as it is a software-based system. The device adheres to regulatory standards for infusion safety management and is authorized for distribution in the United States.
Other devices from ICU Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the LifeShield Infusion Safety Software Suite used for?
The LifeShield Infusion Safety Software Suite is designed to enhance patient safety during intravenous infusion therapy in hospital environments. It integrates with ICU Medical’s Plum Duo and Plum Solo infusion pumps to provide real-time safety alerts, dose verification, and compliance tracking. This helps prevent medication errors by monitoring infusion administration and ensuring adherence to prescribed protocols.
How is the LifeShield Infusion Safety Software Suite supplied?
The LifeShield Infusion Safety Software Suite is supplied as a digital solution, meaning it is not a physical device but rather a software-based system. It is compatible with ICU Medical’s Plum Duo and Plum Solo infusion pumps and is intended for use in general hospital settings. No physical packaging or sterility requirements apply, as it operates entirely through software integration.
Is the LifeShield Infusion Safety Software Suite sterile or single-use?
No, the LifeShield Infusion Safety Software Suite is neither sterile nor single-use. It is classified as a reusable, non-sterile Class II medical device under FDA 510(k) clearance. Since it is a software-based system, it does not require sterilization or disposal after use, but it must be maintained and updated as specified by the manufacturer to ensure ongoing functionality and safety.
Which infusion pumps is the LifeShield Infusion Safety Software Suite compatible with?
The LifeShield Infusion Safety Software Suite is specifically designed to integrate with ICU Medical’s Plum Duo and Plum Solo infusion pumps. Compatibility is limited to these models, ensuring seamless real-time safety monitoring and dose verification during infusion therapy. Always verify compatibility with the latest software updates from ICU Medical.
What regulatory pathway was used for FDA clearance of the LifeShield Infusion Safety Software Suite?
The LifeShield Infusion Safety Software Suite received FDA 510(k) clearance through the Traditional pathway, with a clearance number of K252130. This pathway was used to demonstrate that the device is substantially equivalent to legally marketed predicates. The product code assigned is PHC, indicating its classification as an infusion safety management software for general hospital use.