Cleared Traditional

K031812 - TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 (FDA 510(k) Clearance)

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

K031812 · Vascular Control Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
183d
Days
Class 2
Risk

K031812 is an FDA 510(k) clearance for the TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03. 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 December 12, 2003 after a review of 183 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 K031812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2003
Decision Date December 12, 2003
Days to Decision 183 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
76d slower than avg
Panel avg: 107d · This submission: 183d
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.

Regulatory Peers - DXC Clamp, Vascular

All 201
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K031812.
Life Saving Tourniquet
K254060 · TW Medical · Apr 2026
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · Medline Industries, LP · Nov 2025
Radial Compression Device
K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Jan 2024
PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · Compression Works, Inc. · Mar 2023