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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 / K251295

510(k) cleared

ulrichINJECT CT Motion (XD 8000)

Ulrich GmbH & Co. KG · Nov 7, 2025 · K251295

FDA cleared the ulrichINJECT CT Motion (XD 8000) from Ulrich GmbH & Co. KG on Nov 7, 2025 under K251295, a traditional 510(k). The device falls under product code IZQ, Injector, Contrast Medium, Automatic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 25, 2025. The decision came 196 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ulrich GmbH & Co. KG has 2 other decisions in the tracker over the last 12 months: K252087 (Navigation Module of the Cortium® System), K252281 (ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)).

Questions & Answers

What did FDA clear under K251295?

K251295 is the FDA 510(k) for ulrichINJECT CT Motion (XD 8000), submitted by Ulrich GmbH & Co. KG. FDA's decision date was Nov 7, 2025, under product code IZQ (Injector, Contrast Medium, Automatic).

Who makes the ulrichINJECT CT Motion (XD 8000)?

Ulrich GmbH & Co. KG, based in Ulm, is the applicant of record for K251295.

How long did the K251295 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Nov 7, 2025, 196 days later.

← All decisions in November 2025

Sources