Cleared Traditional

K915550 - MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915550 · Koven and Assoc., Inc. · Radiology device
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Dec 1992
Decision
365d
Days
Class 2
Risk

K915550 is an FDA 510(k) clearance for the MINI DOPPLER II ULTRASOUND 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 December 10, 1992 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 and Assoc., Inc. devices

Submission Details

510(k) Number K915550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1991
Decision Date December 10, 1992
Days to Decision 365 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
258d slower than avg
Panel avg: 107d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 136
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