Panels › Obstetrics/Gynecology › Product code KNG · Class 2
Monitor, Ultrasonic, Fetal
Regulation 884.2660
1510(k)s in 12 months (60 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in KNG
| Company | 510(k)s | Recalls |
|---|---|---|
| Edan Instruments, Inc. | 6 | 0 |
| Huntleigh Technology, Inc. | 3 | 0 |
| Advanced Instrumentations, Inc. | 2 | 0 |
| Contec Medical Systems Co.,Ltd | 2 | 0 |
| Koven Technology, Inc. | 2 | 0 |
| Kt Medical, Inc. | 2 | 0 |
| Medasonics, Inc. | 2 | 0 |
| Medsonics | 2 | 0 |
| Pie Data Medical BV | 2 | 0 |
| Shenzhen Bestman Instrument Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 8, 2026 | K252669 | Fetal Doppler U8-25, U9-25 Zhongshan Xiaolan Town Senlan Electronic Factory, CN | KNG |
| Jun 26, 2025 | K242846 | Doppler FHR Detector (BF-500D+, BF-560) Shenzhen Bestman Instrument Co., Ltd., CN | KNG |
| Jun 28, 2024 | K233823 | Ultrasonic Fetal Doppler Shenzhen Jamr Technology Co., Ltd., CN | KNG |
| Jun 14, 2024 | K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) Contec Medical Systems Co.,Ltd, CN | KNG |
| Sep 28, 2022 | K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) Contec Medical Systems Co.,Ltd, CN | KNG |
| Jan 7, 2022 | K211940 | Fetal Doppler Shenzhen Taikang Medical Equipment Co., Ltd., CN | KNG |
| Nov 3, 2021 | K212084 | Fetal Doppler Shenzhen Mericonn Technology Co., Ltd., CN | KNG |
| Nov 14, 2019 | K191110 | HeraBEAT US Heramed, Ltd., IL | KNG |
| May 29, 2019 | K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) Vcomin Technology Limited, CN | KNG |
| Mar 1, 2019 | K182710 | Fetal Doppler, Model FD88 Shenzzhen Luckcome Technology Inc., Ltd., CN | KNG |
| Dec 19, 2018 | K182190 | Fetal Doppler Shenzhen AOJ Medical Technology Co., Ltd., CN | KNG |
| Jul 19, 2018 | K180419 | Ultrasonic Doppler (Model YM-2T8) Shenzhen Imdk Medical Technology Co., Ltd., CN | KNG |
| Jun 6, 2018 | K172780 | SD1 Ultrasonic Pocket Doppler Edan Instruments, Inc., CN | KNG |
| Jan 29, 2016 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler Edan Instruments, Inc., CN | KNG |
| Feb 6, 2015 | K140579 | ULTRASONIC POCKET DOPPLER Edan Instruments, Inc., CN | KNG |
| Jan 24, 2014 | K131457 | FETAL ULTRASONIC MONITOR AND ACCESSORIES Shenzhen Jumper Medical Equipment Co., Ltd., CN | KNG |
| Oct 27, 2011 | K112911 | FETAL DOPPLER Beijing Choice Electronic Technololgy Co., Ltd., CN | KNG |
| Oct 27, 2011 | K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER Advanced Instrumentations, Inc. | KNG |
| Sep 22, 2011 | K111934 | PD-100 SERIES ULTRASONIC POCKET DOPPLER Advanced Instrumentations, Inc. | KNG |
| Jun 24, 2011 | K110630 | F10 Mediana Co., Ltd., KR | KNG |
| Feb 4, 2011 | K110124 | FETAL DOPPLER JPD-100S Shenzhen Jumper Medical Equipment Co., Ltd., CN | KNG |
| May 21, 2010 | K100626 | DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 Shenzhen Biocare Electronics Co., Ltd., CN | KNG |
| Apr 29, 2010 | K090510 | DOPPLER FETAL HEARTBEAT RATE DETECTOR Shenzhen Bestman Instrument Co., Ltd., CN | KNG |
| Nov 10, 2009 | K092997 | ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 Edan Instruments, Inc. | KNG |
| Feb 25, 2009 | K082480 | CONTEC POCKET FETAL DOPPLER Contec Medical System Co., Ltd., CN | KNG |
| Feb 6, 2009 | K082055 | MODEL PC-860 FETAL DOPPLER Shenzhen Creative Industry Co., Ltd., CN | KNG |
| Mar 11, 2008 | K080087 | SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR Edan Instruments, Inc. | KNG |
| May 4, 2006 | K061091 | BABYBEAT CORDLESS The Newman Group, LLC | KNG |
| May 25, 2004 | K040480 | SONOTRAX ULTRASONIC POCKET DOPPLER Edan Instruments, Inc. | KNG |
| Dec 9, 2003 | K033156 | OB1 OBSTETRICAL DOPPLER D. E. Hokanson, Inc. | KNG |
| Sep 12, 2003 | K030466 | HANDYDOP Elcat, GmbH | KNG |
| Jul 18, 2003 | K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX Koven Technology, Inc. | KNG |
| Jan 3, 2003 | K024197 | LIFEDOP DOPPLER Summit Doppler Systems, Inc. | KNG |
| Dec 19, 2002 | K023143 | ECHO SOUNDER, ES-102EX Koven Technology, Inc. | KNG |
| Feb 20, 2002 | K013547 | BABYCOM Pmg Medica , Ltd., IL | KNG |
| Dec 28, 1999 | K991441 | CADENCE DOPPLER ULTRASOUND SYSTEM Medasonics, Inc. | KNG |
| Jun 24, 1994 | K930200 | MULTI DOPPLEX II / FETAL DOPPLEX II Huntleigh Healthcare, Inc. | KNG |
| Dec 11, 1992 | K920056 | POCKET SIZE FETAL HEART DETECTOR Medical Accessories, Inc. | KNG |
| Jun 20, 1991 | K911453 | OBTRASOUND STETHOSCOPE FETAL CALC Medasonics, Inc. | KNG |
| Mar 29, 1991 | K910153 | UST-974-5 CONVEX TRANSDUCER Ge Medical Systems Information Technologies | KNG |
| Jul 2, 1990 | K901593 | IMEX DOP-TONE II Imex Medical Systems, Inc. | KNG |
| Apr 25, 1990 | K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 Huntleigh Technology, Inc. | KNG |
| Mar 29, 1989 | K890139 | TOITU DOPPLER FETUS DETECTOR, FD-400D Toitu of America, Inc. | KNG |
| Feb 2, 1988 | K870653 | ULTRASOUND LINEAR/SECTOR SCANNER 1100 Pie Data Medical BV, NL | KNG |
| Feb 2, 1988 | K870058 | PIE MEDICAL SCANNER 1000 Pie Data Medical BV, NL | KNG |
| Jul 9, 1986 | K854267 | HUNTLEIGH DOPCORD, D140 Huntleigh Technology, Inc. | KNG |
| Feb 21, 1986 | K852655 | COMBISCOPE Instrument Technology, Inc. | KNG |
| Jun 19, 1984 | K841805 | OBSTETRICAL DOPPLER Epcom Medical Systems, Inc. | KNG |
| Jan 8, 1983 | K823242 | PROGRAMALITH PROGRAMMER Pacesetter Systems | KNG |
| Nov 25, 1981 | K812868 | FETAL PULSE DETECTORS, F50/F60 South Carolina Medical, Inc. | KNG |
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