Cleared Traditional

K082480 - CONTEC POCKET FETAL DOPPLER

K082480 is an FDA 510(k) clearance for CONTEC POCKET FETAL DOPPLER, manufactured by Contec Medical System Co., Ltd.. The device is a Class 2 Radiology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K082480

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
Combination Product No
PCCP Authorized No
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.

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 57
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K082480.
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
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DOPPLER FETAL HEARTBEAT RATE DETECTOR
K090510 · Shenzhen Bestman Instrument Co., Ltd. · Apr 2010
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009
MODEL PC-860 FETAL DOPPLER
K082055 · Shenzhen Creative Industry Co., Ltd. · Feb 2009
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
K080087 · Edan Instruments, Inc. · Mar 2008
BABYBEAT CORDLESS
K061091 · The Newman Group, LLC · May 2006
K082480 · CONTEC POCKET FETAL DOPPLER
Download PDF FDA Summary Contec Medical System…