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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 / April 2026 / K252728

510(k) cleared

IDS-iSYS Total Testosterone

Immunodiagnostic Systems Limited · Apr 15, 2026 · K252728

FDA cleared the IDS-iSYS Total Testosterone from Immunodiagnostic Systems Limited on Apr 15, 2026 under K252728, a traditional 510(k). The device falls under product code CDZ, Radioimmunoassay, Testosterones And Dihydrotestosterone, regulated at 21 CFR 862.1680 as a Class 1 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 28, 2025. The decision came 230 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 Immunodiagnostic Systems Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252728?

K252728 is the FDA 510(k) for IDS-iSYS Total Testosterone, submitted by Immunodiagnostic Systems Limited. FDA's decision date was Apr 15, 2026, under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone).

Who makes the IDS-iSYS Total Testosterone?

Immunodiagnostic Systems Limited, based in Tyne & Wear, is the applicant of record for K252728.

How long did the K252728 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Apr 15, 2026, 230 days later.

← All decisions in April 2026