Cleared Traditional

K092997 - ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 (FDA 510(k) Clearance)

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

K092997 · Edan Instruments, Inc. · Radiology device

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Nov 2009

Decision

43d

Days

Class 2

Risk

K092997 is an FDA 510(k) clearance for the ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on November 10, 2009 after a review of 43 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 Edan Instruments, Inc. devices

Submission Details

510(k) Number	K092997 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2009
Decision Date	November 10, 2009
Days to Decision	43 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

64d faster than avg

Panel avg: 107d · This submission: 43d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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.