KNG · Monitor, Ultrasonic, Fetal
Obstetrics/Gynecology · 21 CFR 884.2660 · Class 2
Overview
| Product Code | KNG |
|---|---|
| Device Name | Monitor, Ultrasonic, Fetal |
| Regulation | 21 CFR 884.2660 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | Jan 8, 2026 | SESE |
| K242846 | Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. | Jun 26, 2025 | SESE |
| K233823 | Ultrasonic Fetal Doppler | Shenzhen Jamr Technology Co., Ltd. | Jun 28, 2024 | SESE |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | Contec Medical Systems Co.,Ltd | Jun 14, 2024 | SESE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | Sep 28, 2022 | SESE |
| K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | Jan 7, 2022 | SESE |
| K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | Nov 3, 2021 | SESE |
| K191110 | HeraBEAT US | Heramed, Ltd. | Nov 14, 2019 | SESE |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) | Vcomin Technology Limited | May 29, 2019 | SESE |
| K182710 | Fetal Doppler, Model FD88 | Shenzzhen Luckcome Technology Inc., Ltd. | Mar 1, 2019 | SESE |
| K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | Dec 19, 2018 | SESE |
| K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | Jul 19, 2018 | SESE |
| K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | Jun 6, 2018 | SESE |
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | Jan 29, 2016 | SESE |
| K140579 | ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | Feb 6, 2015 | SESE |
| K131457 | FETAL ULTRASONIC MONITOR AND ACCESSORIES | Shenzhen Jumper Medical Equipment Co., Ltd. | Jan 24, 2014 | SESE |
| K112911 | FETAL DOPPLER | Beijing Choice Electronic Technololgy Co., Ltd. | Oct 27, 2011 | SESE |
| K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER | Advanced Instrumentations, Inc. | Oct 27, 2011 | SESE |
| K111934 | PD-100 SERIES ULTRASONIC POCKET DOPPLER | Advanced Instrumentations, Inc. | Sep 22, 2011 | SESE |
| K110630 | F10 | Mediana Co., Ltd. | Jun 24, 2011 | SESE |
Top Applicants
- Edan Instruments, Inc. — 6 clearances
- Huntleigh Technology, Inc. — 3 clearances
- Advanced Instrumentations, Inc. — 2 clearances
- Contec Medical Systems Co.,Ltd — 2 clearances
- Koven Technology, Inc. — 2 clearances
