Cleared Traditional

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

K252281 · Ulrich GmbH & Co. KG · General Hospital
Nov 2025
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K252281 is an FDA 510(k) clearance for the ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180), a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on November 18, 2025, 119 days after receiving the submission on July 22, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K252281 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2025
Decision Date November 18, 2025
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code IZQ — Injector, Contrast Medium, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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