Atlas FDA

KNG

60 FDA 510(k) clearances · Product code

113 daysmedian time to decision
337 days90th percentile
60clearances measured

FDA profile

Official device name
Monitor, Ultrasonic, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2660
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 2 · 1996: 1 · 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Fetal Doppler U8-25, U9-25 (K252669)Zhongshan Xiaolan Town Senlan Electronic Factory2026-01-08
Doppler FHR Detector (BF-500D+, BF-560) (K242846)Shenzhen Bestman Instrument Co., Ltd.2025-06-26
Ultrasonic Fetal Doppler (K233823)Shenzhen Jamr Technology Co., Ltd.2024-06-28
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) (K232893)Contec Medical Systems Co.,Ltd2024-06-14
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (K220245)Contec Medical Systems Co.,Ltd2022-09-28
Fetal Doppler (K211940)Shenzhen Taikang Medical Equipment Co., Ltd.2022-01-07
Fetal Doppler (K212084)Shenzhen Mericonn Technology Co., Ltd.2021-11-03
HeraBEATâ„¢ US (K191110)Heramed, Ltd.2019-11-14
Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) (K182526)Vcomin Technology Limited2019-05-29
Fetal Doppler, Model FD88 (K182710)Shenzzhen Luckcome Technology Inc., Ltd.2019-03-01
Fetal Doppler (K182190)Shenzhen AOJ Medical Technology Co., Ltd.2018-12-19
Ultrasonic Doppler (Model YM-2T8) (K180419)Shenzhen Imdk Medical Technology Co., Ltd.2018-07-19
SD1 Ultrasonic Pocket Doppler (K172780)Edan Instruments, Inc.2018-06-06
SD5 & SD6 Ultrasonic Tabletop Doppler (K153475)Edan Instruments, Inc.2016-01-29
ULTRASONIC POCKET DOPPLER (K140579)Edan Instruments, Inc.2015-02-06
FETAL ULTRASONIC MONITOR AND ACCESSORIES (K131457)Shenzhen Jumper Medical Equipment Co., Ltd.2014-01-24
FETAL DOPPLER (K112911)Beijing Choice Electronic Technololgy Co., Ltd.2011-10-27
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER (K112529)Advanced Instrumentations, Inc.2011-10-27
PD-100 SERIES ULTRASONIC POCKET DOPPLER (K111934)Advanced Instrumentations, Inc.2011-09-22
F10 (K110630)Mediana Co., Ltd.2011-06-24
FETAL DOPPLER JPD-100S (K110124)Shenzhen Jumper Medical Equipment Co., Ltd.2011-02-04
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 (K100626)Shenzhen Biocare Electronics Co., Ltd.2010-05-21
DOPPLER FETAL HEARTBEAT RATE DETECTOR (K090510)Shenzhen Bestman Instrument Co., Ltd.2010-04-29
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 (K092997)Edan Instruments, Inc.2009-11-10
CONTEC POCKET FETAL DOPPLER (K082480)Contec Medical System Co., Ltd.2009-02-25
MODEL PC-860 FETAL DOPPLER (K082055)Shenzhen Creative Industry Co., Ltd.2009-02-06
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR (K080087)Edan Instruments, Inc.2008-03-11
BABYBEAT CORDLESS (K061091)The Newman Group, LLC2006-05-04
SONOTRAX ULTRASONIC POCKET DOPPLER (K040480)Edan Instruments, Inc.2004-05-25
OB1 OBSTETRICAL DOPPLER (K033156)D. E. Hokanson, Inc.2003-12-09
HANDYDOP (K030466)Elcat, GmbH2003-09-12
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX (K031504)Koven Technology, Inc.2003-07-18
LIFEDOP DOPPLER (K024197)Summit Doppler Systems, Inc.2003-01-03
ECHO SOUNDER, ES-102EX (K023143)Koven Technology, Inc.2002-12-19
BABYCOM (K013547)Pmg Medica , Ltd.2002-02-20
CADENCE DOPPLER ULTRASOUND SYSTEM (K991441)Medasonics, Inc.1999-12-28
MULTI DOPPLEX II / FETAL DOPPLEX II (K930200)Huntleigh Healthcare, Inc.1994-06-24
POCKET SIZE FETAL HEART DETECTOR (K920056)Medical Accessories, Inc.1992-12-11
OBTRASOUND STETHOSCOPE FETAL CALC (K911453)Medasonics, Inc.1991-06-20
UST-974-5 CONVEX TRANSDUCER (K910153)Ge Medical Systems Information Technologies1991-03-29
IMEX DOP-TONE II (K901593)Imex Medical Systems, Inc.1990-07-02
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 (K900618)Huntleigh Technology, Inc.1990-04-25
TOITU DOPPLER FETUS DETECTOR, FD-400D (K890139)Toitu of America, Inc.1989-03-29
PIE MEDICAL SCANNER 1000 (K870058)Pie Data Medical BV1988-02-02
ULTRASOUND LINEAR/SECTOR SCANNER 1100 (K870653)Pie Data Medical BV1988-02-02
HUNTLEIGH DOPCORD, D140 (K854267)Huntleigh Technology, Inc.1986-07-09
COMBISCOPE (K852655)Instrument Technology, Inc.1986-02-21
OBSTETRICAL DOPPLER (K841805)Epcom Medical Systems, Inc.1984-06-19
PROGRAMALITH PROGRAMMER (K823242)Pacesetter Systems1983-01-08
FETAL PULSE DETECTORS, F50/F60 (K812868)South Carolina Medical, Inc.1981-11-25
DOPPLEX-PLB & PXB (K810115)Huntleigh Technology, Inc.1981-07-16
GRAVIDAPHONE (K802024)Solar Electronics1981-01-07
FETAL HEART DETECTOR #'S D102 & D102R (K800858)Sonicaid, Inc.1980-05-14
FETAL HEART DETECTOR #D206 (K800859)Sonicaid, Inc.1980-05-14
MINIFETON 200 (K800098)Kt Medical, Inc.1980-02-11
MGD-3 (K800095)Kt Medical, Inc.1980-02-11
SA/7860 FETAL HEART MONITOR (DOPPLER) (K790951)Schlosser Alberti Co.1979-08-03
PROBE, BLOOD FLOW DETECTOR PLUG-IN (K770904)Medsonics1977-05-26
MODEL 6/60 CRT VIDEO-SONAR (K760888)Vexilar, Inc.1977-02-01
CONTINUOUS WAVE DOPPLER ULTRASOUND (K760728)Medsonics1976-10-06

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