LifeShield Infusion Safety Software Suite
510(k) K223606
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223606 | Date24 Aug 2023 | StatusActive |
Recalls
-
- Ongoing Z-1763-2025
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
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- Withdrawn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, 19 Sep 2026
The LifeShield Infusion Safety Software Suite is an Infusion Safety Management Software designed to enhance the safety and efficiency of intravenous (IV) infusion therapy. It integrates with infusion pumps to monitor and manage infusion processes, reducing the risk of medication errors, infusion-related complications, and adverse events in clinical settings.
This software is intended for use in General Hospital environments, supporting seamless collaboration among healthcare teams. Supplied as a digital solution, it is not single-use or reusable but requires compatible hardware (e.g., Plum Duo or Plum Solo infusion pumps) for operation. The system operates under FDA 510(k) clearance (K223606, PHC classification, Regulation 880.5725) and is classified as a Class II medical device. No sterility or physical packaging specifications are provided.
Other devices from ICU Medical, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of infusion pumps does the LifeShield Infusion Safety Software Suite work with, and how is it supplied?
The LifeShield Infusion Safety Software Suite is designed to integrate with specific ICU Medical infusion pumps, such as the Plum Duo and Plum Solo. Since it is a digital solution, it is not supplied as a physical device but rather as software that requires compatible hardware to function. No physical packaging or sterility considerations apply, as it operates entirely on connected infusion pumps.
Is the LifeShield Infusion Safety Software Suite intended for use in specific clinical settings, and how does it improve patient safety?
The software is intended for use in General Hospital environments, where it enhances safety and efficiency by monitoring and managing IV infusion processes. It helps reduce medication errors, infusion-related complications, and adverse events by providing real-time oversight and collaboration tools for healthcare teams.
How is the LifeShield Infusion Safety Software Suite regulated, and what does its FDA clearance status mean for hospitals?
The LifeShield Infusion Safety Software Suite holds FDA 510(k) clearance (K223606) under the Plastic and Reusable Hospital Equipment (PHC) classification, classified as a Class II medical device. This means it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and performance in hospital settings.
Can the LifeShield Infusion Safety Software Suite be reused across multiple patients, or is it designed for single-use?
Unlike physical medical devices, the LifeShield Infusion Safety Software Suite is not single-use or reusable in the traditional sense. It operates as a permanent digital solution integrated with infusion pumps, continuously monitoring and managing infusion therapy for multiple patients in a clinical setting. Its functionality depends on the underlying hardware, not disposable components.