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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 / January 2026 / K253957

510(k) cleared

HemosIL Silica Clotting Time

Instrumentation Laboratory (IL) Co. · Jan 9, 2026 · K253957

FDA cleared the HemosIL Silica Clotting Time from Instrumentation Laboratory (IL) Co. on Jan 9, 2026 under K253957, a special 510(k). The device falls under product code GFO, Activated 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 Dec 10, 2025. 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: K260551 (HemosIL Factor V Leiden (APC Resistance V)).

Questions & Answers

What did FDA clear under K253957?

K253957 is the FDA 510(k) for HemosIL Silica Clotting Time, submitted by Instrumentation Laboratory (IL) Co.. FDA's decision date was Jan 9, 2026, under product code GFO (Activated Partial Thromboplastin).

Who makes the HemosIL Silica Clotting Time?

Instrumentation Laboratory (IL) Co., based in Bedford, MA, is the applicant of record for K253957.

How long did the K253957 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Jan 9, 2026, 30 days later.

← All decisions in January 2026

Sources