Cleared Traditional

K031504 - ECHO SOUNDER

K031504 is an FDA 510(k) clearance for ECHO SOUNDER, manufactured by Koven Technology, Inc.. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K031504 · Koven Technology, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
65d
Days
Class 2
Risk

K031504 is an FDA 510(k) clearance for the ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Koven Technology, Inc. devices

FDA 510(k) Submission Details - K031504

510(k) Number K031504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2003
Decision Date July 18, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - KNG Monitor, Ultrasonic, Fetal

All 24
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K031504.
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