Cleared Special

MEDRAD Mark 7 Arterion Injection System (K193028) - FDA 510(k) Clearance

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

K193028 · Bayer Medical Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
36d
Days
Class 2
Risk

K193028 is an FDA 510(k) clearance for the MEDRAD Mark 7 Arterion Injection System. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on December 5, 2019 after a review of 36 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 Bayer Medical Care, Inc. devices

Submission Details

510(k) Number K193028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2019
Decision Date December 05, 2019
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
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 Peers - DXT Injector And Syringe, Angiographic

All 48
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K193028.
Sterile High-pressure Angiographic Syringes for single-use
K201395 · Youwo (Guangzhou) Medical Device Co., Ltd. · Oct 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2020
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · Bayer Medical Care, Inc. · Dec 2019
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
K190102 · Osprey Medical, Inc. · Oct 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
K191060 · Acist Medical Systems, Inc. · Jul 2019
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
K183267 · Osprey Medical, Inc. · Dec 2018