Cleared Traditional

K220245 - Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (FDA 510(k) Clearance)

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

K220245 · Contec Medical Systems Co.,Ltd · Obstetrics & Gynecology device
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Sep 2022
Decision
243d
Days
Class 2
Risk

K220245 is an FDA 510(k) clearance for the Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL). Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on September 28, 2022 after a review of 243 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 Contec Medical Systems Co.,Ltd devices

Submission Details

510(k) Number K220245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2022
Decision Date September 28, 2022
Days to Decision 243 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
83d slower than avg
Panel avg: 160d · This submission: 243d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K220245.
Fetal Doppler U8-25, U9-25
K252669 · Zhongshan Xiaolan Town Senlan Electronic Factory · Jan 2026
Doppler FHR Detector (BF-500D+, BF-560)
K242846 · Shenzhen Bestman Instrument Co., Ltd. · Jun 2025
Ultrasonic Fetal Doppler
K233823 · Shenzhen Jamr Technology Co., Ltd. · Jun 2024
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
K232893 · Contec Medical Systems Co.,Ltd · Jun 2024
Fetal Doppler
K211940 · Shenzhen Taikang Medical Equipment Co., Ltd. · Jan 2022
Fetal Doppler
K212084 · Shenzhen Mericonn Technology Co., Ltd. · Nov 2021