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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Entela, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 121
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K031091.
QUANTIX/OR DEVICE
K030357 · Cardiosonix, Ltd. · Aug 2003
CARDIOQ, MODEL 9051-7005
K031706 · Deltex Medical · Aug 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp. · May 2003
QUANTIX/ND DEVICE
K023431 · Cardiosonix, Ltd. · Nov 2002
QFLOW 500 PERFUSION MONITORING SYSTEM
K013376 · Hemedex Incorporated · May 2002
FLOWGUARD DEVICE
K013803 · Biosonix , Ltd. · Feb 2002
K031091 · VTI 20 MHZ GATED DOPPLER
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