Cleared Traditional

K082055 - MODEL PC-860 FETAL DOPPLER

K082055 is an FDA 510(k) clearance for MODEL PC-860 FETAL DOPPLER, manufactured by Shenzhen Creative Industry Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K082055 · Shenzhen Creative Industry Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K082055

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.

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 24
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K082055.
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc. · Feb 2015
FETAL DOPPLER
K112911 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 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
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · Edan Instruments, Inc. · May 2004
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991