Cleared Traditional

K072886 - MEDRAD STELLANT CT INJECTOR SYSTEM WITH...

K072886 is the FDA 510(k) clearance for MEDRAD STELLANT CT INJECTOR SYSTEM WITH... by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K072886 · Medrad, Inc. · Cardiovascular device
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Dec 2007
Decision
73d
Days
Class 2
Risk

K072886 is an FDA 510(k) clearance for the MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medrad, Inc. devices

Submission Details

510(k) Number K072886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date December 21, 2007
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K072886.
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
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MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
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K061976 · Toshiba America Medical Systems, In.C · Sep 2006
MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
K050456 · Medrad, Inc. · Jun 2005
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
K042784 · Medrad, Inc. · Dec 2004