Cleared Traditional

K182526 - Fetal Doppler (Models: FD-231B

K182526 is the FDA 510(k) clearance for Fetal Doppler (Models: FD-231B by Vcomin Technology Limited. It is a Class 2 Obstetrics & Gynecology device (product code KNG) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K182526 · Vcomin Technology Limited · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 2019
Decision
260d
Days
Class 2
Risk

K182526 is an FDA 510(k) clearance for the Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, .... Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Vcomin Technology Limited (Shenzhen, CN). The FDA issued a Cleared decision on May 29, 2019 after a review of 260 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 Vcomin Technology Limited devices

Submission Details

510(k) Number K182526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2018
Decision Date May 29, 2019
Days to Decision 260 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
100d slower than avg
Panel avg: 160d · This submission: 260d
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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Lucy Yan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 19
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K182526.
Fetal Doppler
K211940 · Shenzhen Taikang Medical Equipment Co., Ltd. · Jan 2022
Fetal Doppler
K212084 · Shenzhen Mericonn Technology Co., Ltd. · Nov 2021
HeraBEAT™ US
K191110 · Heramed, Ltd. · Nov 2019
Fetal Doppler, Model FD88
K182710 · Shenzzhen Luckcome Technology Inc., Ltd. · Mar 2019
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