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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K252130

510(k) cleared

LifeShield Infusion Safety Software Suite

Icu Medical, Inc. · Apr 2, 2026 · K252130

FDA cleared the LifeShield Infusion Safety Software Suite from Icu Medical, Inc. on Apr 2, 2026 under K252130, a traditional 510(k). The device falls under product code PHC, Infusion Safety Management Software, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 7, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Icu Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K252006 (OTTO Disinfecting Cap), K251980 (ClaveQS Bag).

Questions & Answers

What did FDA clear under K252130?

K252130 is the FDA 510(k) for LifeShield Infusion Safety Software Suite, submitted by Icu Medical, Inc.. FDA's decision date was Apr 2, 2026, under product code PHC (Infusion Safety Management Software).

Who makes the LifeShield Infusion Safety Software Suite?

Icu Medical, Inc., based in Lake Forest, IL, is the applicant of record for K252130.

How long did the K252130 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Apr 2, 2026, 269 days later.

← All decisions in April 2026

Sources