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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 / K260551

510(k) cleared

HemosIL Factor V Leiden (APC Resistance V)

Instrumentation Laboratory (IL) Co. · Mar 20, 2026 · K260551

FDA cleared the HemosIL Factor V Leiden (APC Resistance V) from Instrumentation Laboratory (IL) Co. on Mar 20, 2026 under K260551, a special 510(k). The device falls under product code GGW, Test, Time, Partial Thromboplastin, regulated at 21 CFR 864.7925 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Feb 18, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Instrumentation Laboratory (IL) Co. has one other decision in the tracker over the last 12 months: K253957 (HemosIL Silica Clotting Time).

Questions & Answers

What did FDA clear under K260551?

K260551 is the FDA 510(k) for HemosIL Factor V Leiden (APC Resistance V), submitted by Instrumentation Laboratory (IL) Co.. FDA's decision date was Mar 20, 2026, under product code GGW (Test, Time, Partial Thromboplastin).

Who makes the HemosIL Factor V Leiden (APC Resistance V)?

Instrumentation Laboratory (IL) Co., based in Bedford, MA, is the applicant of record for K260551.

How long did the K260551 review take?

FDA received the submission on Feb 18, 2026 and issued its decision on Mar 20, 2026, 30 days later.

← All decisions in March 2026

Sources