Cleared Traditional

K192370 - MEDRAD Stellant FLEX CT Injection Syste...

K192370 is an FDA 510(k) clearance for MEDRAD Stellant FLEX CT Injection Syste..., manufactured by Bayer Medical Care, Inc.. The device is a Class 2 General Hospital device with product code DXT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K192370 · Bayer Medical Care, Inc. · General Hospital
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Dec 2019
Decision
105d
Days
Class 2
Risk

K192370 is an FDA 510(k) clearance for the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Bayer Medical Care, Inc. (Whippany, US). The FDA issued a Cleared decision on December 13, 2019 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Medical Care, Inc. devices

FDA 510(k) Submission Details - K192370

510(k) Number K192370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date December 13, 2019
Days to Decision 105 days
Submission Type Traditional
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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K192370.
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