LifeShield Infusion Safety Software Suite— 510(k) K252130
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K252130 for LifeShield Infusion Safety Software Suite, Substantially Equivalent on 2026-04-02. Applicant: Icu Medical, Inc.. Device class: 2.
Summary
ICU Medical's LifeShield Infusion Safety Software Suite is filed under product code PHC (Infusion Safety Management Software). The record doesn't describe the suite beyond its name and that code name.
Class II, 21 CFR 880.5725. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).
ICU Medical filed from Lake Forest, Illinois. The record shows 269 calendar days from receipt to decision (July 7, 2025 to April 2, 2026).
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Product code PHC
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, IL, US
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