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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 / K243920

510(k) cleared

Purema H Hemoconcentrator - Pediatric

Medica USA, Inc. · Sep 19, 2025 · K243920

FDA cleared the Purema H Hemoconcentrator - Pediatric from Medica USA, Inc. on Sep 19, 2025 under K243920, a traditional 510(k). The device falls under product code KDI, Dialyzer, High Permeability With Or Without Sealed Dialysate System, regulated at 21 CFR 876.5860 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 20, 2024. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medica USA, Inc. has 2 other decisions in the tracker over the last 12 months: K250679 (FFX Facet Fixation System), K252153 (FFX Facet Fixation System).

Questions & Answers

What did FDA clear under K243920?

K243920 is the FDA 510(k) for Purema H Hemoconcentrator - Pediatric, submitted by Medica USA, Inc.. FDA's decision date was Sep 19, 2025, under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System).

Who makes the Purema H Hemoconcentrator - Pediatric?

Medica USA, Inc., based in Minnetonka, MN, is the applicant of record for K243920.

How long did the K243920 review take?

FDA received the submission on Dec 20, 2024 and issued its decision on Sep 19, 2025, 273 days later.

← All decisions in September 2025

Sources