Cleared Traditional

K010452 - BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER

K010452 is an FDA 510(k) clearance for BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, manufactured by Koven Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K010452 · Koven Technology, Inc. · Cardiovascular device
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Feb 2002
Decision
362d
Days
Class 2
Risk

K010452 is an FDA 510(k) clearance for the BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on February 12, 2002 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Koven Technology, Inc. devices

FDA 510(k) Submission Details - K010452

510(k) Number K010452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2001
Decision Date February 12, 2002
Days to Decision 362 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 125d · This submission: 362d
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 39
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K010452.
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
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CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp. · May 2003
MS DISPOSABLE RIGID DOPPLER PROBE
K930227 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1993
CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)
K925524 · Cardio Metrics, Inc. · Aug 1993
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991