Cleared Special

K252689 - MEDRAD Centargo CT Injection System (FDA 510(k) Clearance)

Also includes:
MEDRAD Centargo Day Set MEDRAD Centargo Patient Line MEDRAD Centargo Replacement Spike MEDRAD ISI2 Module (ISI2)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252689 · Imaxeon Pty, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
29d
Days
Class 2
Risk

K252689 is an FDA 510(k) clearance for the MEDRAD Centargo CT Injection System. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Imaxeon Pty, Ltd. (Rydalmere, AU). The FDA issued a Cleared decision on September 24, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imaxeon Pty, Ltd. devices

Submission Details

510(k) Number K252689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2025
Decision Date September 24, 2025
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Bayer Medical Care, Inc.
Gopal Abbineni

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 21
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K252689.
ulricheasyINJECT Max 2M (XD 10140)
K252281 · Ulrich GmbH & Co. KG · Nov 2025
ulrichINJECT CT Motion (XD 8000)
K251295 · Ulrich GmbH & Co. KG · Nov 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
ulrichINJECT CT motion
K210541 · Ulrich GmbH & Co. KG · Aug 2021