Cleared Traditional

K920333 - SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

K920333 is an FDA 510(k) clearance for SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW D..., manufactured by Koven and Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K920333 · Koven and Assoc., Inc. · Cardiovascular device
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Jan 1993
Decision
361d
Days
Class 2
Risk

K920333 is an FDA 510(k) clearance for the SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Koven and Assoc., Inc. (St. Louis, US). The FDA issued a Cleared decision on January 22, 1993 after a review of 361 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 and Assoc., Inc. devices

FDA 510(k) Submission Details - K920333

510(k) Number K920333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date January 22, 1993
Days to Decision 361 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
236d slower than avg
Panel avg: 125d · This submission: 361d
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 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K920333.
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
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MS DISPOSABLE RIGID DOPPLER PROBE
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K925524 · Cardio Metrics, Inc. · Aug 1993
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991
INTERSPEC APOGEE, MODIFICATION
K910049 · Interspec, Inc. · Apr 1991
FLOWIRE AND FLOMAP
K905411 · Cardio Metrics, Inc. · Mar 1991