Cleared Traditional

K040228 - MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122

K040228 is an FDA 510(k) clearance for MEDI-STIM VERIQ SYSTEM, manufactured by Medi-Stim A/S. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K040228 · Medi-Stim A/S · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
87d
Days
Class 2
Risk

K040228 is an FDA 510(k) clearance for the MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Medi-Stim A/S (Brooklyn Park, US). The FDA issued a Cleared decision on April 29, 2004 after a review of 87 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 - K040228

510(k) Number K040228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date April 29, 2004
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 137
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K040228.
QUANTIX/OR BLOOD FLOW MONITOR
K050088 · Neoprobe Corp. · Feb 2005
QUANTIX OR VESSEL STABILIZER DEVICE
K041180 · Cardiosonix, Ltd. · Jun 2004
SENSILASE PAD 3000
K040654 · Optical Sensors, Inc. · Jun 2004
SONO TT ULTRASONIC FLOWCOMPUTER
K040909 · Em-Tec GmbH · Apr 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · Koven Technology, Inc. · Feb 2004
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K033424 · Transonic Systems, Inc. · Dec 2003
K040228 · MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
Download PDF FDA Summary Medi-Stim A/S