LifeShield Infusion Safety Software Suite— 510(k) K252130

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K252130 for LifeShield Infusion Safety Software Suite, Substantially Equivalent on 2026-04-02. Applicant: Icu Medical, Inc..

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code PHC
Advisory panel: General Hospital
Date received: 2025-07-07
Decision date: 2026-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

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