Cleared Traditional

MODEL PC-860 FETAL DOPPLER (K082055) - FDA 510(k) Clearance

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

K082055 · Shenzhen Creative Industry Co., Ltd. · Obstetrics & Gynecology device
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Feb 2009
Decision
200d
Days
Class 2
Risk

K082055 is an FDA 510(k) clearance for the MODEL PC-860 FETAL DOPPLER. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Shenzhen Creative Industry Co., Ltd. (Chenzhen City, CN). The FDA issued a Cleared decision on February 6, 2009 after a review of 200 days - an extended review cycle.

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 Shenzhen Creative Industry Co., Ltd. devices

Submission Details

510(k) Number K082055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2008
Decision Date February 06, 2009
Days to Decision 200 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 160d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 14
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K082055.
Fetal Doppler
K182190 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2018
Ultrasonic Doppler (Model YM-2T8)
K180419 · Shenzhen Imdk Medical Technology Co., Ltd. · Jul 2018
SD1 Ultrasonic Pocket Doppler
K172780 · Edan Instruments, Inc. · Jun 2018
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991