Cleared Traditional

K171392 - ulrichINJECT CT motion (FDA 510(k) Clearance)

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

K171392 · Ulrich GmbH & Co. KG · Cardiovascular device
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Nov 2017
Decision
182d
Days
Class 2
Risk

K171392 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 November 9, 2017 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ulrich GmbH & Co. KG devices

Submission Details

510(k) Number K171392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date November 09, 2017
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
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 Cardiovascular 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 K171392.
ulricheasyINJECT Max 2M (XD 10140)
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ulrichINJECT CT Motion (XD 8000)
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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