Cleared Traditional

K251295 - ulrichINJECT CT Motion (XD 8000) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251295 · Ulrich GmbH & Co. KG · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2025
Decision
196d
Days
Class 2
Risk

K251295 is an FDA 510(k) clearance for the ulrichINJECT CT Motion (XD 8000). Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on November 7, 2025 after a review of 196 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ulrich GmbH & Co. KG devices

Submission Details

510(k) Number K251295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2025
Decision Date November 07, 2025
Days to Decision 196 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 128d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZQ Injector, Contrast Medium, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

MethodSense, Inc.
Rita King

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZQ Injector, Contrast Medium, Automatic

All 21
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K251295.
ulricheasyINJECT Max 2M (XD 10140)
K252281 · Ulrich GmbH & Co. KG · Nov 2025
MEDRAD Centargo CT Injection System
K252689 · Imaxeon Pty, Ltd. · Sep 2025
MEDRAD Centargo CT Injection System
K241849 · Imaxeon Pty, Ltd. · Nov 2024
ulricheasyINJECT Max 2M (XD 10140)
K241850 · Ulrich GmbH & Co. KG · Aug 2024
ulricheasyINJECT Max 2M (XD 10140)
K233737 · Ulrich GmbH & Co. KG · Apr 2024
ulrichINJECT CT motion
K210541 · Ulrich GmbH & Co. KG · Aug 2021