Cleared Traditional

K180419 - Ultrasonic Doppler (Model YM-2T8) (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

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 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K180419.
Fetal Doppler U8-25, U9-25
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Doppler FHR Detector (BF-500D+, BF-560)
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Ultrasonic Fetal Doppler
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Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
K232893 · Contec Medical Systems Co.,Ltd · Jun 2024
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245 · Contec Medical Systems Co.,Ltd · Sep 2022
Fetal Doppler
K211940 · Shenzhen Taikang Medical Equipment Co., Ltd. · Jan 2022