Doppler FHR Detector (BF-500D+, BF-560)
FDA 510(k) K242846 · Shenzhen Bestman Instrument Co., Ltd.
510(k) numberK242846
Submission
- Device name
- Doppler FHR Detector (BF-500D+, BF-560)
- Applicant
- Shenzhen Bestman Instrument Co., Ltd.
Shenzhen, CN - Received
- September 20, 2024
- Decision date
- June 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNG – Monitor, Ultrasonic, Fetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K252669 | Fetal Doppler U8-25, U9-25KNG · Traditional | Zhongshan Xiaolan Town Senlan Electronic Factory | 01/08/2026SE |
| K233823 | Ultrasonic Fetal DopplerKNG · Traditional | Shenzhen Jamr Technology Co., Ltd. | 06/28/2024SE |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional | Contec Medical Systems Co.,Ltd | 06/14/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | Contec Medical Systems Co.,Ltd | 09/28/2022SE |
| K211940 | Fetal DopplerKNG · Traditional | Shenzhen Taikang Medical Equipment Co., Ltd. | 01/07/2022SE |
| K212084 | Fetal DopplerKNG · Traditional | Shenzhen Mericonn Technology Co., Ltd. | 11/03/2021SE |
| K191110 | HeraBEAT USKNG · Traditional | Heramed, Ltd. | 11/14/2019SE |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…KNG · Traditional | Vcomin Technology Limited | 05/29/2019SE |
| K182710 | Fetal Doppler, Model FD88KNG · Traditional | Shenzzhen Luckcome Technology Inc., Ltd. | 03/01/2019SE |
| K182190 | Fetal DopplerKNG · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 12/19/2018SE |
More from Shenzhen AOJ Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K090510 | Doppler Fetal Heartbeat Rate DetectorKNG · Traditional | 04/29/2010SE |
Questions and answers
When was Doppler FHR Detector (BF-500D+, BF-560) cleared by the FDA?
Doppler FHR Detector (BF-500D+, BF-560) (K242846) received a 510(k) decision of Substantially Equivalent on June 26, 2025, 279 days after the submission was received.
What is the product code of K242846?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.