Cleared Traditional

OptiOne Single-Head Contrast Delivery System with Pedestal (K152361) - FDA 510(k) Clearance

Also marketed or referenced as:
with Ceiling Suspension Injector, OptiOne Base System

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

K152361 · Liebel-Flarsheim Company, LLC · Cardiovascular device
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Jan 2016
Decision
147d
Days
Class 2
Risk

K152361 is an FDA 510(k) clearance for the OptiOne Single-Head Contrast Delivery System with Pedestal. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Liebel-Flarsheim Company, LLC (Cincinnati, US). The FDA issued a Cleared decision on January 14, 2016 after a review of 147 days - within the typical 510(k) review window.

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 Liebel-Flarsheim Company, LLC devices

Submission Details

510(k) Number K152361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date January 14, 2016
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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
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K241850 · Ulrich GmbH & Co. KG · Aug 2024
ulricheasyINJECT Max 2M (XD 10140)
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