Cleared Traditional

K991441 - CADENCE DOPPLER ULTRASOUND SYSTEM (FDA 510(k) Clearance)

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

K991441 · Medasonics, Inc. · Radiology device
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Dec 1999
Decision
246d
Days
Class 2
Risk

K991441 is an FDA 510(k) clearance for the CADENCE DOPPLER ULTRASOUND SYSTEM. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Medasonics, Inc. (Sandy, US). The FDA issued a Cleared decision on December 28, 1999 after a review of 246 days - an extended review 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: 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 Medasonics, Inc. devices

Submission Details

510(k) Number K991441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date December 28, 1999
Days to Decision 246 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
139d slower than avg
Panel avg: 107d · This submission: 246d
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.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 59
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