Cleared Traditional

K031091 - VTI 20 MHZ GATED DOPPLER

K031091 is an FDA 510(k) clearance for VTI 20 MHZ GATED DOPPLER, manufactured by Vascular Technology Incorporated. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K031091 · Vascular Technology Incorporated · Cardiovascular device
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Apr 2003
Decision
16d
Days
Class 2
Risk

K031091 is an FDA 510(k) clearance for the VTI 20 MHZ GATED DOPPLER. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Vascular Technology Incorporated (Lowell, US). The FDA issued a Cleared decision on April 23, 2003 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascular Technology Incorporated devices

FDA 510(k) Submission Details - K031091

510(k) Number K031091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date April 23, 2003
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 65
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K031091.
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
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MONITOR, MODEL HSM-00200
K031153 · Arrow Intl., Inc. · Nov 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp. · May 2003
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · Koven Technology, Inc. · Feb 2002
JOSTRA HL-20 TWIN PUMP
K984338 · Jostra Bentley · Aug 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
K992387 · Rossmax International , Ltd. · Aug 1999