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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 / K250471

510(k) cleared

AquaC UNO H

Fresenius Medical Care Renal Therapies Group, LLC · Nov 14, 2025 · K250471

FDA cleared the AquaC UNO H from Fresenius Medical Care Renal Therapies Group, LLC on Nov 14, 2025 under K250471, a traditional 510(k). The device falls under product code FIP, Subsystem, Water Purification, regulated at 21 CFR 876.5665 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 18, 2025. The decision came 269 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 K250471?

K250471 is the FDA 510(k) for AquaC UNO H, submitted by Fresenius Medical Care Renal Therapies Group, LLC. FDA's decision date was Nov 14, 2025, under product code FIP (Subsystem, Water Purification).

Who makes the AquaC UNO H?

Fresenius Medical Care Renal Therapies Group, LLC, based in Waltham, MA, is the applicant of record for K250471.

How long did the K250471 review take?

FDA received the submission on Feb 18, 2025 and issued its decision on Nov 14, 2025, 269 days later.

← All decisions in November 2025