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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 / K250634

510(k) cleared

BCM2-Body Composition Monitor

Fresenius Medical Care Renal Therapies Group, LLC · Nov 24, 2025 · K250634

FDA cleared the BCM2-Body Composition Monitor from Fresenius Medical Care Renal Therapies Group, LLC on Nov 24, 2025 under K250634, a traditional 510(k). The device falls under product code DSB, Plethysmograph, Impedance, regulated at 21 CFR 870.2770 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 3, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fresenius Medical Care Renal Therapies Group, LLC has 8 other decisions in the tracker over the last 12 months: K261267 (Careflux H60;Careflux H70;Careflux V500), K252377 (NxStage System One with NxView), K252459 (multiFlux 130 (F00013123); multiFlux 160 (F00013124)), K253462 (NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)).

Questions & Answers

What did FDA clear under K250634?

K250634 is the FDA 510(k) for BCM2-Body Composition Monitor, submitted by Fresenius Medical Care Renal Therapies Group, LLC. FDA's decision date was Nov 24, 2025, under product code DSB (Plethysmograph, Impedance).

Who makes the BCM2-Body Composition Monitor?

Fresenius Medical Care Renal Therapies Group, LLC, based in Waltham, MA, is the applicant of record for K250634.

How long did the K250634 review take?

FDA received the submission on Mar 3, 2025 and issued its decision on Nov 24, 2025, 266 days later.

← All decisions in November 2025