KNG · Class II · 21 CFR 884.2660

FDA Product Code KNG: Monitor, Ultrasonic, Fetal

Leading manufacturers include Contec Medical Systems Co.,Ltd, Vcomin Technology Limited and Shenzzhen Luckcome Technology Inc., Ltd..

60
Total
60
Cleared
146d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 208d recently vs 144d historically

FDA 510(k) Cleared Monitor, Ultrasonic, Fetal Devices (Product Code KNG)

60 devices
1–24 of 60
Cleared Jan 08, 2026
Fetal Doppler U8-25, U9-25
K252669
Zhongshan Xiaolan Town Senlan Electronic Factory
Obstetrics & Gynecology · 136d
Cleared Jun 26, 2025
Doppler FHR Detector (BF-500D+, BF-560)
K242846
Shenzhen Bestman Instrument Co., Ltd.
Obstetrics & Gynecology · 279d
Cleared Jun 28, 2024
Ultrasonic Fetal Doppler
K233823
Shenzhen Jamr Technology Co., Ltd.
Obstetrics & Gynecology · 210d
Cleared Jun 14, 2024
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
K232893
Contec Medical Systems Co.,Ltd
Obstetrics & Gynecology · 270d
Cleared Sep 28, 2022
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245
Contec Medical Systems Co.,Ltd
Obstetrics & Gynecology · 243d
Cleared Jan 07, 2022
Fetal Doppler
K211940
Shenzhen Taikang Medical Equipment Co., Ltd.
Obstetrics & Gynecology · 198d
Cleared Nov 03, 2021
Fetal Doppler
K212084
Shenzhen Mericonn Technology Co., Ltd.
Obstetrics & Gynecology · 124d
Cleared Nov 14, 2019
HeraBEAT™ US
K191110
Heramed, Ltd.
Obstetrics & Gynecology · 202d
Cleared May 29, 2019
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
K182526
Vcomin Technology Limited
Obstetrics & Gynecology · 260d
Cleared Mar 01, 2019
Fetal Doppler, Model FD88
K182710
Shenzzhen Luckcome Technology Inc., Ltd.
Obstetrics & Gynecology · 155d
Cleared Dec 19, 2018
Fetal Doppler
K182190
Shenzhen AOJ Medical Technology Co., Ltd.
Obstetrics & Gynecology · 128d
Cleared Jul 19, 2018
Ultrasonic Doppler (Model YM-2T8)
K180419
Shenzhen Imdk Medical Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Jun 06, 2018
SD1 Ultrasonic Pocket Doppler
K172780
Edan Instruments, Inc.
Obstetrics & Gynecology · 265d

About Product Code KNG - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code KNG since 1976, with 60 receiving FDA clearance (average review time: 146 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - KNG Product Code

Recent submissions under KNG have taken an average of 208 days to reach a decision - up from 144 days historically. Manufacturers should account for longer review timelines in current project planning.

KNG devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →