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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 / May 2026 / K260235

510(k) cleared

CellDx-Tissue

Datar Cancer Genetics Private Limited · May 12, 2026 · K260235

FDA cleared the CellDx-Tissue from Datar Cancer Genetics Private Limited on May 12, 2026 under K260235, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code PZM, Next Generation Sequencing Based Tumor Profiling Test, regulated at 21 CFR 866.6080 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Jan 26, 2026. The decision came 106 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 Datar Cancer Genetics Private Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260235?

K260235 is the FDA 510(k) for CellDx-Tissue, submitted by Datar Cancer Genetics Private Limited. FDA's decision date was May 12, 2026, under product code PZM (Next Generation Sequencing Based Tumor Profiling Test).

Who makes the CellDx-Tissue?

Datar Cancer Genetics Private Limited, based in Nasik, is the applicant of record for K260235.

How long did the K260235 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on May 12, 2026, 106 days later.

← All decisions in May 2026