Cleared Traditional

K954397 - BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY

K954397 is an FDA 510(k) clearance for BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY, manufactured by Koven Technology, Inc.. The device is a Class 2 Radiology device with product code DPW cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K954397 · Koven Technology, Inc. · Radiology device
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Mar 1996
Decision
191d
Days
Class 2
Risk

K954397 is an FDA 510(k) clearance for the BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Koven Technology, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 191 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2100 - 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 Koven Technology, Inc. devices

FDA 510(k) Submission Details - K954397

510(k) Number K954397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1995
Decision Date March 29, 1996
Days to Decision 191 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 107d · This submission: 191d
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 Radiology 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 K954397.
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
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MONITOR, MODEL HSM-00200
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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