Cleared Traditional

K912409 - MODEL HD-207 BIDIRECTIONAL VELOCITY METER

K912409 is an FDA 510(k) clearance for MODEL HD-207 BIDIRECTIONAL VELOCITY METER, manufactured by Koven and Assoc., Inc.. The device is a Class 2 Radiology device with product code JOP cleared through the Traditional 510(k) pathway after a 206-day FDA review.

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

FDA 510(k) Submission Details - K912409

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.

JOP Device Classification - Class 2, Special Controls

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 55
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K912409.
STUDIODOP VICORDER
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K934638 · Koven Technology, Inc. · May 1994
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369 · Ge Medical Systems Information Technologies · Feb 1991
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264 · Millar Instruments, Inc. · Jan 1990
CARDIAC COMPUTATION SOFTWARE PACKAGE
K890636 · Elscint, Inc. · Aug 1989