Cleared Traditional

K032125 - CSTAT, MODELS 09-0014-01 AND 09-0014-02 (FDA 510(k) Clearance)

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

K032125 · Vascular Control Systems, Inc. · Radiology device
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Feb 2004
Decision
214d
Days
Class 2
Risk

K032125 is an FDA 510(k) clearance for the CSTAT, MODELS 09-0014-01 AND 09-0014-02. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vascular Control Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on February 9, 2004 after a review of 214 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.4450 - the FDA radiology and imaging software 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vascular Control Systems, Inc. devices

Submission Details

510(k) Number K032125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2003
Decision Date February 09, 2004
Days to Decision 214 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 107d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Radiology devices follow this clearance model.

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