Cleared Traditional

K032125 - CSTAT, MODELS 09-0014-01 AND 09-0014-02

K032125 is an FDA 510(k) clearance for CSTAT, manufactured by Vascular Control Systems, Inc.. The device is a Class 2 Radiology device with product code DXC cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K032125 · Vascular Control Systems, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K032125

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
Combination Product No
PCCP Authorized No
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.

DXC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DXC Clamp, Vascular

All 199
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K032125.
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K040615 · Advanced Vascular Dynamics · Jun 2004
PORTACLAMP
K033085 · Cardio Life Research, S.A. · Apr 2004
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · Vascular Control Systems, Inc. · Dec 2003
ENCLOSE II ANASTOMOSIS ASSIST DEVICE
K032589 · Novare Surgical Systems, Inc. · Sep 2003
ENCLOSE ANASTOMOSIS ASSIST DEVICE
K023682 · Novare Surgical Systems, Inc. · Jan 2003
K032125 · CSTAT, MODELS 09-0014-01 AND 09-0014-02
Download PDF FDA Summary Vascular Control Syst…