Cleared Traditional

K080087 - SONOTRAX ULTRASONIC FETAL AND VASCULAR ...

K080087 is the FDA 510(k) clearance for SONOTRAX ULTRASONIC FETAL AND VASCULAR ... by Edan Instruments, Inc.. It is a Class 2 Radiology device (product code KNG) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K080087 · Edan Instruments, Inc. · Radiology device
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Mar 2008
Decision
60d
Days
Class 2
Risk

K080087 is an FDA 510(k) clearance for the SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PR.... 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 March 11, 2008 after a review of 60 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 K080087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2008
Decision Date March 11, 2008
Days to Decision 60 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
47d faster than avg
Panel avg: 107d · This submission: 60d
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 20
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K080087.
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc. · Feb 2015
FETAL DOPPLER
K112911 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2011
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · Edan Instruments, Inc. · May 2004
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991
PROGRAMALITH PROGRAMMER
K823242 · Pacesetter Systems · Jan 1983