Cleared Traditional

K140579 - ULTRASONIC POCKET DOPPLER

K140579 is the FDA 510(k) clearance for ULTRASONIC POCKET DOPPLER by Edan Instruments, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code KNG) cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K140579 · Edan Instruments, Inc. · Obstetrics & Gynecology device
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Feb 2015
Decision
337d
Days
Class 2
Risk

K140579 is an FDA 510(k) clearance for the ULTRASONIC POCKET DOPPLER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on February 6, 2015 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - the FDA obstetrics and gynecology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K140579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2014
Decision Date February 06, 2015
Days to Decision 337 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 160d · This submission: 337d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 19
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K140579.
Ultrasonic Doppler (Model YM-2T8)
K180419 · Shenzhen Imdk Medical Technology Co., Ltd. · Jul 2018
SD1 Ultrasonic Pocket Doppler
K172780 · Edan Instruments, Inc. · Jun 2018
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · Edan Instruments, Inc. · Jan 2016
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009
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