Cleared Special

K011991 - MODIFICATION TO MEDRAD SPECTRIS MR INJE...

K011991 is the FDA 510(k) clearance for MODIFICATION TO MEDRAD SPECTRIS MR INJE... by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Special 510(k) pathway after a 56-day FDA review.

K011991 · Medrad, Inc. · Cardiovascular device
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Aug 2001
Decision
56d
Days
Class 2
Risk

K011991 is an FDA 510(k) clearance for the MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR. 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 August 21, 2001 after a review of 56 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. 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 Medrad, Inc. devices

Submission Details

510(k) Number K011991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2001
Decision Date August 21, 2001
Days to Decision 56 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
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 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 K011991.
MEDRAD QWIK-FIT SYRINGE
K013815 · Medrad, Inc. · Dec 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · Medrad, Inc. · Oct 2001
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc. · Nov 2000
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · Medrad, Inc. · Nov 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc. · Jul 1999