Cleared Traditional

K904792 - DIAGNOSTIC ULTRASOUND VERSADOPP 1000

K904792 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND VERSADOPP 1000, manufactured by Diagnostic Ultrasound Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K904792 · Diagnostic Ultrasound Corp. · Cardiovascular device
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Jan 1991
Decision
97d
Days
Class 2
Risk

K904792 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND VERSADOPP 1000. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Diagnostic Ultrasound Corp. (Kirkland, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Diagnostic Ultrasound Corp. devices

FDA 510(k) Submission Details - K904792

510(k) Number K904792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1990
Decision Date January 28, 1991
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 35
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K904792.
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