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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 / September 2025 / DEN240067

510(k) cleared

KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

Cytocell Limited · Sep 19, 2025 · DEN240067

FDA cleared the KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) from Cytocell Limited on Sep 19, 2025 under DEN240067, a direct 510(k). The device falls under product code SFS, Revumenib Eligibility Detection System, regulated at 21 CFR 864.1885 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Nov 22, 2024. The decision came 301 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 Cytocell Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN240067?

DEN240067 is the FDA 510(k) for KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013), submitted by Cytocell Limited. FDA's decision date was Sep 19, 2025, under product code SFS (Revumenib Eligibility Detection System).

Who makes the KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)?

Cytocell Limited, based in Cambridge, is the applicant of record for DEN240067.

How long did the DEN240067 review take?

FDA received the submission on Nov 22, 2024 and issued its decision on Sep 19, 2025, 301 days later.

← All decisions in September 2025