Cleared Traditional

MODEL HD-207 BIDIRECTIONAL VELOCITY METER (K912409) - FDA 510(k) Clearance

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

K912409 · Koven and Assoc., Inc. · Radiology device
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Dec 1991
Decision
206d
Days
Class 2
Risk

K912409 is an FDA 510(k) clearance for the MODEL HD-207 BIDIRECTIONAL VELOCITY METER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Koven and Assoc., Inc. (St. Louis, US). The FDA issued a Cleared decision on December 23, 1991 after a review of 206 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2880 - 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 and Assoc., Inc. devices

Submission Details

510(k) Number K912409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1991
Decision Date December 23, 1991
Days to Decision 206 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
99d slower than avg
Panel avg: 107d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 13
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