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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 / January 2026 / K253462

510(k) cleared

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

Fresenius Medical Care Renal Therapies Group, LLC · Jan 29, 2026 · K253462

FDA cleared the NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) from Fresenius Medical Care Renal Therapies Group, LLC on Jan 29, 2026 under K253462, a traditional 510(k). The device falls under product code KPO, Dialysate Concentrate For Hemodialysis (Liquid Or Powder), regulated at 21 CFR 876.5820 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Oct 7, 2025. The decision came 114 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)), K253518 (FX CorAL 40; FX CorAL 50).

Questions & Answers

What did FDA clear under K253462?

K253462 is the FDA 510(k) for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2), submitted by Fresenius Medical Care Renal Therapies Group, LLC. FDA's decision date was Jan 29, 2026, under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)).

Who makes the NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

Fresenius Medical Care Renal Therapies Group, LLC, based in Waltham, MA, is the applicant of record for K253462.

How long did the K253462 review take?

FDA received the submission on Oct 7, 2025 and issued its decision on Jan 29, 2026, 114 days later.

← All decisions in January 2026