Cleared Traditional

K192872 - ulrichINJECT CT Motion (FDA 510(k) Clearance)

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

K192872 · Ulrich GmbH & Co. KG · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
268d
Days
Class 2
Risk

K192872 is an FDA 510(k) clearance for the ulrichINJECT CT Motion. 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 July 2, 2020 after a review of 268 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 K192872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2019
Decision Date July 02, 2020
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 128d · This submission: 268d
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 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 K192872.
ulricheasyINJECT Max 2M (XD 10140)
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ulrichINJECT CT Motion (XD 8000)
K251295 · 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