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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 / March 2026 / K251980

510(k) cleared

ClaveQS Bag

Icu Medical, Inc. · Mar 20, 2026 · K251980

FDA cleared the ClaveQS Bag from Icu Medical, Inc. on Mar 20, 2026 under K251980, a traditional 510(k). The device falls under product code KPE, Container, I.V., regulated at 21 CFR 880.5025 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 27, 2025. The decision came 266 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: K252130 (LifeShield Infusion Safety Software Suite), K252006 (OTTO Disinfecting Cap).

Questions & Answers

What did FDA clear under K251980?

K251980 is the FDA 510(k) for ClaveQS Bag, submitted by Icu Medical, Inc.. FDA's decision date was Mar 20, 2026, under product code KPE (Container, I.V.).

Who makes the ClaveQS Bag?

Icu Medical, Inc., based in San Clemente, CA, is the applicant of record for K251980.

How long did the K251980 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Mar 20, 2026, 266 days later.

← All decisions in March 2026

Sources