KNG · Class II · 21 CFR 884.2660

FDA Product Code KNG: Monitor, Ultrasonic, Fetal

Leading manufacturers include Edan Instruments, Inc., Huntleigh Technology, Inc. and Koven Technology, Inc..

60
Total
60
Cleared
146d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
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
Cleared Jan 29, 2016
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475
Edan Instruments, Inc.
Radiology · 58d
Cleared Feb 06, 2015
ULTRASONIC POCKET DOPPLER
K140579
Edan Instruments, Inc.
Obstetrics & Gynecology · 337d
Cleared Jan 24, 2014
FETAL ULTRASONIC MONITOR AND ACCESSORIES
K131457
Shenzhen Jumper Medical Equipment Co., Ltd.
Obstetrics & Gynecology · 249d
Cleared Oct 27, 2011
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
K112529
Advanced Instrumentations, Inc.
Radiology · 57d
Cleared Oct 27, 2011
FETAL DOPPLER
K112911
Beijing Choice Electronic Technololgy Co., Ltd.
Radiology · 24d
Cleared Sep 22, 2011
PD-100 SERIES ULTRASONIC POCKET DOPPLER
K111934
Advanced Instrumentations, Inc.
Radiology · 76d
Cleared Jun 24, 2011
F10
K110630
Mediana Co., Ltd.
Obstetrics & Gynecology · 113d
Cleared Feb 04, 2011
FETAL DOPPLER JPD-100S
K110124
Shenzhen Jumper Medical Equipment Co., Ltd.
Radiology · 17d
Cleared Nov 10, 2009
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997
Edan Instruments, Inc.
Radiology · 43d
Cleared Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
K080087
Edan Instruments, Inc.
Radiology · 60d
Cleared May 04, 2006
BABYBEAT CORDLESS
K061091
The Newman Group, LLC
Radiology · 15d

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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.

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 →