Cleared Traditional

K180419 - Ultrasonic Doppler (Model YM-2T8)

K180419 is an FDA 510(k) clearance for Ultrasonic Doppler (Model YM-2T8), manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K180419 · Shenzhen Imdk Medical Technology Co., Ltd. · Obstetrics & Gynecology device
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Jul 2018
Decision
154d
Days
Class 2
Risk

K180419 is an FDA 510(k) clearance for the Ultrasonic Doppler (Model YM-2T8). Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 19, 2018 after a review of 154 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 Imdk Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K180419

510(k) Number K180419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2018
Decision Date July 19, 2018
Days to Decision 154 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 160d · This submission: 154d
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 Obstetrics & Gynecology 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 K180419.
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
K182526 · Vcomin Technology Limited · May 2019
Fetal Doppler, Model FD88
K182710 · Shenzzhen Luckcome Technology Inc., Ltd. · Mar 2019
Fetal Doppler
K182190 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2018
SD1 Ultrasonic Pocket Doppler
K172780 · Edan Instruments, Inc. · Jun 2018
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · Edan Instruments, Inc. · Jan 2016
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc. · Feb 2015