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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 / October 2025 / K250159

510(k) cleared

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

The Binding Site Group , Ltd. · Oct 17, 2025 · K250159

FDA cleared the Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser from The Binding Site Group , Ltd. on Oct 17, 2025 under K250159, a traditional 510(k). The device falls under product code SGG, Mass Spectrometric, Immunoglobulins (G, A, M, D, E), regulated at 21 CFR 866.5510 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Jan 21, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for The Binding Site Group , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250159?

K250159 is the FDA 510(k) for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser, submitted by The Binding Site Group , Ltd.. FDA's decision date was Oct 17, 2025, under product code SGG (Mass Spectrometric, Immunoglobulins (G, A, M, D, E)).

Who makes the Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

The Binding Site Group , Ltd., based in Birmingham, is the applicant of record for K250159.

How long did the K250159 review take?

FDA received the submission on Jan 21, 2025 and issued its decision on Oct 17, 2025, 269 days later.

← All decisions in October 2025