Cleared Traditional

VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS (K033266) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033266 · Medical Imaging Applications, LLC · Cardiovascular device
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Dec 2004
Decision
434d
Days
Class 2
Risk

K033266 is an FDA 510(k) clearance for the VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASC.... Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Medical Imaging Applications, LLC (Coralville, US). The FDA issued a Cleared decision on December 16, 2004 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medical Imaging Applications, LLC devices

Submission Details

510(k) Number K033266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2003
Decision Date December 16, 2004
Days to Decision 434 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 125d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 171
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