Cleared Traditional

K092997 - ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6

K092997 is an FDA 510(k) clearance for ULTRASONIC TABLETOP DOPPLER, manufactured by Edan Instruments, Inc.. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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

FDA 510(k) Submission Details - K092997

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
Combination Product No
PCCP Authorized No
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.

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 39
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K092997.
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