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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 / K252006

510(k) cleared

OTTO Disinfecting Cap

Icu Medical, Inc. · Mar 27, 2026 · K252006

FDA cleared the OTTO Disinfecting Cap from Icu Medical, Inc. on Mar 27, 2026 under K252006, a traditional 510(k). The device falls under product code QBP, Cap, Device Disinfectant, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 27, 2025. The decision came 273 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), K251980 (ClaveQS Bag).

Questions & Answers

What did FDA clear under K252006?

K252006 is the FDA 510(k) for OTTO Disinfecting Cap, submitted by Icu Medical, Inc.. FDA's decision date was Mar 27, 2026, under product code QBP (Cap, Device Disinfectant).

Who makes the OTTO Disinfecting Cap?

Icu Medical, Inc., based in San Clemente, CA, is the applicant of record for K252006.

How long did the K252006 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Mar 27, 2026, 273 days later.

← All decisions in March 2026

Sources