Cleared Traditional

K082480 - CONTEC POCKET FETAL DOPPLER

K082480 is the FDA 510(k) clearance for CONTEC POCKET FETAL DOPPLER by Contec Medical System Co., Ltd.. It is a Class 2 Radiology device (product code KNG) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K082480 · Contec Medical System Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
181d
Days
Class 2
Risk

K082480 is an FDA 510(k) clearance for the CONTEC POCKET FETAL DOPPLER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Contec Medical System Co., Ltd. (Zhong Shan, Shanghai, CN). The FDA issued a Cleared decision on February 25, 2009 after a review of 181 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 Contec Medical System Co., Ltd. devices

Submission Details

510(k) Number K082480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date February 25, 2009
Days to Decision 181 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
74d slower than avg
Panel avg: 107d · This submission: 181d
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 K082480.
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · Edan Instruments, Inc. · Jan 2016
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc. · Feb 2015
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
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991