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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 / June 2026 / K261099

510(k) cleared

Blood Volume Analyzer (200)

Daxor Corporation · Jun 18, 2026 · K261099

FDA cleared the Blood Volume Analyzer (200) from Daxor Corporation on Jun 18, 2026 under K261099, a special 510(k). The device falls under product code JWO, Device, Blood Volume Measuring, regulated at 21 CFR 864.5950 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Apr 2, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Daxor Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261099?

K261099 is the FDA 510(k) for Blood Volume Analyzer (200), submitted by Daxor Corporation. FDA's decision date was Jun 18, 2026, under product code JWO (Device, Blood Volume Measuring).

Who makes the Blood Volume Analyzer (200)?

Daxor Corporation, based in Oak Ridge, TN, is the applicant of record for K261099.

How long did the K261099 review take?

FDA received the submission on Apr 2, 2026 and issued its decision on Jun 18, 2026, 77 days later.

← All decisions in June 2026