Product Code: KNG FDA class 2 21 CFR 884.2660

Monitor, Ultrasonic, Fetal

Obstetrics/Gynecology

An Ultrasonic Fetal Monitor is a diagnostic device used in obstetrics to continuously detect and record fetal heart rate using Doppler ultrasound technology, providing real-time assessment of fetal wellbeing during pregnancy and labor. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNG and the applicable regulation is 21 CFR 884.2660 in the Obstetrics and Gynecology specialty. This device is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KNG
Device Class: FDA class 2
Regulation Number: 884.2660
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 60 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252669	Fetal Doppler U8-25, U9-25	Jan 08, 2026	Substantially Equivalent	Zhongshan Xiaolan Town Senlan Electronic Factory
K242846	Doppler FHR Detector (BF-500D+, BF-560)	Jun 26, 2025	Substantially Equivalent	Shenzhen Bestman Instrument Co., Ltd.
K233823	Ultrasonic Fetal Doppler	Jun 28, 2024	Substantially Equivalent	Shenzhen Jamr Technology Co., Ltd.
K232893	Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)	Jun 14, 2024	Substantially Equivalent	Contec Medical Systems Co.,Ltd
K220245	Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)	Sep 28, 2022	Substantially Equivalent	Contec Medical Systems Co.,Ltd
K211940	Fetal Doppler	Jan 07, 2022	Substantially Equivalent	Shenzhen Taikang Medical Equipment Co., Ltd.
K212084	Fetal Doppler	Nov 03, 2021	Substantially Equivalent	Shenzhen Mericonn Technology Co., Ltd.
K191110	HeraBEAT US	Nov 14, 2019	Substantially Equivalent	Heramed, Ltd.
K182526	Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)	May 29, 2019	Substantially Equivalent	Vcomin Technology Limited
K182710	Fetal Doppler, Model FD88	Mar 01, 2019	Substantially Equivalent	Shenzzhen Luckcome Technology Inc., Ltd.
K182190	Fetal Doppler	Dec 19, 2018	Substantially Equivalent	Shenzhen AOJ Medical Technology Co., Ltd.
K180419	Ultrasonic Doppler (Model YM-2T8)	Jul 19, 2018	Substantially Equivalent	Shenzhen Imdk Medical Technology Co., Ltd.
K172780	SD1 Ultrasonic Pocket Doppler	Jun 06, 2018	Substantially Equivalent	Edan Instruments, Inc.
K153475	SD5 & SD6 Ultrasonic Tabletop Doppler	Jan 29, 2016	Substantially Equivalent	Edan Instruments, Inc.
K140579	ULTRASONIC POCKET DOPPLER	Feb 06, 2015	Substantially Equivalent	Edan Instruments, Inc.
K131457	FETAL ULTRASONIC MONITOR AND ACCESSORIES	Jan 24, 2014	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.
K112911	FETAL DOPPLER	Oct 27, 2011	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.
K112529	TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER	Oct 27, 2011	Substantially Equivalent	Advanced Instrumentations, Inc.
K111934	PD-100 SERIES ULTRASONIC POCKET DOPPLER	Sep 22, 2011	Substantially Equivalent	Advanced Instrumentations, Inc.
K110630	F10	Jun 24, 2011	Substantially Equivalent	Mediana Co., Ltd.
K110124	FETAL DOPPLER JPD-100S	Feb 04, 2011	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.
K100626	DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200	May 21, 2010	Substantially Equivalent	Shenzhen Biocare Electronics Co., Ltd.
K090510	DOPPLER FETAL HEARTBEAT RATE DETECTOR	Apr 29, 2010	Substantially Equivalent	Shenzhen Bestman Instrument Co., Ltd.
K092997	ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6	Nov 10, 2009	Substantially Equivalent	Edan Instruments, Inc.
K082480	CONTEC POCKET FETAL DOPPLER	Feb 25, 2009	Substantially Equivalent	Contec Medical System Co., Ltd.
K082055	MODEL PC-860 FETAL DOPPLER	Feb 06, 2009	Substantially Equivalent	Shenzhen Creative Industry Co., Ltd.
K080087	SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR	Mar 11, 2008	Substantially Equivalent	Edan Instruments, Inc.
K061091	BABYBEAT CORDLESS	May 04, 2006	Substantially Equivalent	The Newman Group, LLC
K040480	SONOTRAX ULTRASONIC POCKET DOPPLER	May 25, 2004	Substantially Equivalent	Edan Instruments, Inc.
K033156	OB1 OBSTETRICAL DOPPLER	Dec 09, 2003	Substantially Equivalent	D. E. Hokanson, Inc.
K030466	HANDYDOP	Sep 12, 2003	Substantially Equivalent	Elcat, GmbH
K031504	ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX	Jul 18, 2003	Substantially Equivalent	Koven Technology, Inc.
K024197	LIFEDOP DOPPLER	Jan 03, 2003	Substantially Equivalent	Summit Doppler Systems, Inc.
K023143	ECHO SOUNDER, ES-102EX	Dec 19, 2002	Substantially Equivalent	Koven Technology, Inc.
K013547	BABYCOM	Feb 20, 2002	Substantially Equivalent	Pmg Medica , Ltd.
K991441	CADENCE DOPPLER ULTRASOUND SYSTEM	Dec 28, 1999	Substantially Equivalent	Medasonics, Inc.
K930200	MULTI DOPPLEX II / FETAL DOPPLEX II	Jun 24, 1994	Substantially Equivalent	Huntleigh Healthcare, Inc.
K920056	POCKET SIZE FETAL HEART DETECTOR	Dec 11, 1992	Substantially Equivalent	Medical Accessories, Inc.
K911453	OBTRASOUND STETHOSCOPE FETAL CALC	Jun 20, 1991	Substantially Equivalent	Medasonics, Inc.
K910153	UST-974-5 CONVEX TRANSDUCER	Mar 29, 1991	Substantially Equivalent	Ge Medical Systems Information Technologies
K901593	IMEX DOP-TONE II	Jul 02, 1990	Substantially Equivalent	Imex Medical Systems, Inc.
K900618	HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140	Apr 25, 1990	Substantially Equivalent	Huntleigh Technology, Inc.
K890139	TOITU DOPPLER FETUS DETECTOR, FD-400D	Mar 29, 1989	Substantially Equivalent	Toitu of America, Inc.
K870653	ULTRASOUND LINEAR/SECTOR SCANNER 1100	Feb 02, 1988	Substantially Equivalent	Pie Data Medical BV
K870058	PIE MEDICAL SCANNER 1000	Feb 02, 1988	Substantially Equivalent	Pie Data Medical BV
K854267	HUNTLEIGH DOPCORD, D140	Jul 09, 1986	Substantially Equivalent	Huntleigh Technology, Inc.
K852655	COMBISCOPE	Feb 21, 1986	Substantially Equivalent	Instrument Technology, Inc.
K841805	OBSTETRICAL DOPPLER	Jun 19, 1984	Substantially Equivalent	Epcom Medical Systems, Inc.
K823242	PROGRAMALITH PROGRAMMER	Jan 08, 1983	Substantially Equivalent	Pacesetter Systems
K812868	FETAL PULSE DETECTORS, F50/F60	Nov 25, 1981	Substantially Equivalent	South Carolina Medical, Inc.
K810115	DOPPLEX-PLB & PXB	Jul 16, 1981	Substantially Equivalent	Huntleigh Technology, Inc.
K802024	GRAVIDAPHONE	Jan 07, 1981	Substantially Equivalent	Solar Electronics
K800859	FETAL HEART DETECTOR #D206	May 14, 1980	Substantially Equivalent	Sonicaid, Inc.
K800858	FETAL HEART DETECTOR #'S D102 & D102R	May 14, 1980	Substantially Equivalent	Sonicaid, Inc.
K800098	MINIFETON 200	Feb 11, 1980	Substantially Equivalent	Kt Medical, Inc.
K800095	MGD-3	Feb 11, 1980	Substantially Equivalent	Kt Medical, Inc.
K790951	SA/7860 FETAL HEART MONITOR (DOPPLER)	Aug 03, 1979	Substantially Equivalent	Schlosser Alberti Co.
K770904	PROBE, BLOOD FLOW DETECTOR PLUG-IN	May 26, 1977	Substantially Equivalent	Medsonics
K760888	MODEL 6/60 CRT VIDEO-SONAR	Feb 01, 1977	Substantially Equivalent	Vexilar, Inc.
K760728	CONTINUOUS WAVE DOPPLER ULTRASOUND	Oct 06, 1976	Substantially Equivalent	Medsonics