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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 / K252181

510(k) cleared

AquaA

Fresenius Medical Care North America · Sep 9, 2025 · K252181

FDA cleared the AquaA from Fresenius Medical Care North America on Sep 9, 2025 under K252181, 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 Jul 11, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Fresenius Medical Care North America 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 K252181?

K252181 is the FDA 510(k) for AquaA, submitted by Fresenius Medical Care North America. FDA's decision date was Sep 9, 2025, under product code FIP (Subsystem, Water Purification).

Who makes the AquaA?

Fresenius Medical Care North America, based in Waltham, MA, is the applicant of record for K252181.

How long did the K252181 review take?

FDA received the submission on Jul 11, 2025 and issued its decision on Sep 9, 2025, 60 days later.

← All decisions in September 2025