Cleared Traditional

K252669 - Fetal Doppler U8-25

K252669 is an FDA 510(k) clearance for Fetal Doppler U8-25, manufactured by Zhongshan Xiaolan Town Senlan Electronic Factory. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K252669 · Zhongshan Xiaolan Town Senlan Electronic Factory · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
136d
Days
Class 2
Risk

K252669 is an FDA 510(k) clearance for the Fetal Doppler U8-25, U9-25. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Zhongshan Xiaolan Town Senlan Electronic Factory (Zhongshan, CN). The FDA issued a Cleared decision on January 8, 2026 after a review of 136 days - within the typical 510(k) review window.

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 Zhongshan Xiaolan Town Senlan Electronic Factory devices

FDA 510(k) Submission Details - K252669

510(k) Number K252669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2025
Decision Date January 08, 2026
Days to Decision 136 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
24d faster than avg
Panel avg: 160d · This submission: 136d
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 Consultant

Shenzhen Aisnwei Medical Technology Service Co., Ltd.
Ailing Fu

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 20
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K252669.
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
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
Fetal Doppler
K212084 · Shenzhen Mericonn Technology Co., Ltd. · Nov 2021