Cleared Traditional

K082480 - CONTEC POCKET FETAL DOPPLER (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082480 · Contec Medical System Co., Ltd. · Radiology device
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.

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
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 128d · 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.