Cleared Traditional

K991441 - CADENCE DOPPLER ULTRASOUND SYSTEM

K991441 is an FDA 510(k) clearance for CADENCE DOPPLER ULTRASOUND SYSTEM, manufactured by Medasonics, Inc.. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 246-day FDA review.

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

FDA 510(k) Submission Details - K991441

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
Combination Product No
PCCP Authorized No
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.

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 25
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K991441.
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
K080087 · Edan Instruments, Inc. · Mar 2008
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · Edan Instruments, Inc. · May 2004
OB1 OBSTETRICAL DOPPLER
K033156 · D. E. Hokanson, Inc. · Dec 2003
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618 · Huntleigh Technology, Inc. · Apr 1990
HUNTLEIGH DOPCORD, D140
K854267 · Huntleigh Technology, Inc. · Jul 1986