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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 / June 2026 / K261039

510(k) cleared

i-STAT Crea cartridge with the i-STAT 1 System

Abbott Point of Care, Inc. · Jun 26, 2026 · K261039

FDA cleared the i-STAT Crea cartridge with the i-STAT 1 System from Abbott Point of Care, Inc. on Jun 26, 2026 under K261039, a traditional 510(k). The device falls under product code CGL, Electrode, Ion Based, Enzymatic, Creatinine, regulated at 21 CFR 862.1225 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Mar 30, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Abbott Point of Care, Inc. has one other decision in the tracker over the last 12 months: K253051 (i-STAT hs-TnI cartridge with the i-STAT Alinity System).

Questions & Answers

What did FDA clear under K261039?

K261039 is the FDA 510(k) for i-STAT Crea cartridge with the i-STAT 1 System, submitted by Abbott Point of Care, Inc.. FDA's decision date was Jun 26, 2026, under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine).

Who makes the i-STAT Crea cartridge with the i-STAT 1 System?

Abbott Point of Care, Inc., based in Princeton, NJ, is the applicant of record for K261039.

How long did the K261039 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Jun 26, 2026, 88 days later.

← All decisions in June 2026

Sources