Cleared Traditional

K151048 - CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set

K151048 is an FDA 510(k) clearance for CT Expres 3D Contrast Media Delivery System, manufactured by Bracco Injeneering. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K151048 · Bracco Injeneering · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
277d
Days
Class 2
Risk

K151048 is an FDA 510(k) clearance for the CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III.... Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Bracco Injeneering (Lausanne, CH). The FDA issued a Cleared decision on January 22, 2016 after a review of 277 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.

FDA 510(k) Submission Details - K151048

510(k) Number K151048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date January 22, 2016
Days to Decision 277 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
152d slower than avg
Panel avg: 125d · This submission: 277d
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

Icon Clinical Research, LLC
CYNTHIA NOLTE

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 22
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K151048.
ulrichINJECT CT motion
K210541 · Ulrich GmbH & Co. KG · Aug 2021
ulrichINJECT CT Motion
K192872 · Ulrich GmbH & Co. KG · Jul 2020
ulrichINJECT CT motion
K171392 · Ulrich GmbH & Co. KG · Nov 2017
OptiOne Single-Head Contrast Delivery System with Pedestal
K152361 · Liebel-Flarsheim Company, LLC · Jan 2016
SONIC SHOT GX
K091734 · Nemoto Kyorindo Co., Ltd. · May 2010
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
K063503 · Mallinckrodt Inc., Liebel-Flarsheim Business · Apr 2007
K151048 · CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
Download PDF FDA Summary Bracco Injeneering