Cleared Traditional

K040480 - SONOTRAX ULTRASONIC POCKET DOPPLER

K040480 is an FDA 510(k) clearance for SONOTRAX ULTRASONIC POCKET DOPPLER, manufactured by Edan Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040480 · Edan Instruments, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
90d
Days
Class 2
Risk

K040480 is an FDA 510(k) clearance for the SONOTRAX ULTRASONIC POCKET DOPPLER. 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 May 25, 2004 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K040480

510(k) Number K040480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2004
Decision Date May 25, 2004
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 36
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K040480.
FETAL DOPPLER JPD-100S
K110124 · Shenzhen Jumper Medical Equipment Co., Ltd. · Feb 2011
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
OB1 OBSTETRICAL DOPPLER
K033156 · D. E. Hokanson, Inc. · Dec 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · Koven Technology, Inc. · Jul 2003
ECHO SOUNDER, ES-102EX
K023143 · Koven Technology, Inc. · Dec 2002