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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 / K253051

510(k) cleared

i-STAT hs-TnI cartridge with the i-STAT Alinity System

Abbott Point of Care, Inc. · Jun 11, 2026 · K253051

FDA cleared the i-STAT hs-TnI cartridge with the i-STAT Alinity System from Abbott Point of Care, Inc. on Jun 11, 2026 under K253051, a traditional 510(k). The device falls under product code MMI, Immunoassay Method, Troponin Subunit, regulated at 21 CFR 862.1215 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Sep 22, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Abbott Point of Care, Inc. has one other decision in the tracker over the last 12 months: K261039 (i-STAT Crea cartridge with the i-STAT 1 System).

Questions & Answers

What did FDA clear under K253051?

K253051 is the FDA 510(k) for i-STAT hs-TnI cartridge with the i-STAT Alinity System, submitted by Abbott Point of Care, Inc.. FDA's decision date was Jun 11, 2026, under product code MMI (Immunoassay Method, Troponin Subunit).

Who makes the i-STAT hs-TnI cartridge with the i-STAT Alinity System?

Abbott Point of Care, Inc., based in Princeton, NJ, is the applicant of record for K253051.

How long did the K253051 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 11, 2026, 262 days later.

← All decisions in June 2026

Sources