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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 / November 2025 / K250912

510(k) cleared

IntelliSep Test

Cytovale, Inc. · Nov 19, 2025 · K250912

FDA cleared the IntelliSep Test from Cytovale, Inc. on Nov 19, 2025 under K250912, a traditional 510(k). The device falls under product code QUT, Deformability Cytometry For Sepsis Risk Assessment, regulated at 21 CFR 866.3215 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Mar 27, 2025. The decision came 237 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 Cytovale, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250912?

K250912 is the FDA 510(k) for IntelliSep Test, submitted by Cytovale, Inc.. FDA's decision date was Nov 19, 2025, under product code QUT (Deformability Cytometry For Sepsis Risk Assessment).

Who makes the IntelliSep Test?

Cytovale, Inc., based in South San Francisco, CA, is the applicant of record for K250912.

How long did the K250912 review take?

FDA received the submission on Mar 27, 2025 and issued its decision on Nov 19, 2025, 237 days later.

← All decisions in November 2025