Cleared Traditional

K171392 - ulrichINJECT CT motion

K171392 is an FDA 510(k) clearance for ulrichINJECT CT motion, manufactured by Ulrich GmbH & Co. KG. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

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

FDA 510(k) Submission Details - K171392

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
PCCP Authorized No
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.

IZQ Device Classification - Class 2, Special Controls

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 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 20
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K171392.
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ulrichINJECT CT motion
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ulrichINJECT CT Motion
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