Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, FD-591D)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)

510(k) Number

K182526 ↗

FDA Product Code

KNG

Device Class

Class II

Regulation

21 CFR Part 884.2660

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Fetal Doppler

  Class IIa

  CE/MDR

• Fetal Doppler

  Class IIa

  CE/MDR

• Fetal Doppler

  Class IIa

  CE/MDR

• Fetal Doppler

  Class IIa

  CE/MDR

• How do I determine whether a specific Fetal Doppler model is intended for single-use or reusable applications?

  The Fetal Doppler models from Vcomin Technology Limited are designed for either single-use or reusable applications depending on the specific model. The packaging and manufacturer’s instructions for each model (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, or FD-591D) will indicate whether it is sterile or non-sterile, which directly correlates to its intended use. For example, sterile models are typically intended for single-use in clinical settings, while non-sterile models may be reused after proper cleaning and disinfection as per the manufacturer’s guidelines.

• Are these Fetal Doppler devices compatible with MRI environments, and if not, why?

  The Fetal Doppler devices from Vcomin Technology Limited are not explicitly noted as MRI-compatible in the provided data. Since they employ Doppler ultrasound technology and are handheld, they likely contain electronic components that could pose risks in an MRI environment, such as interference or potential damage from magnetic fields. Clinicians should avoid using these devices near MRI machines unless the manufacturer has explicitly confirmed MRI safety for a specific model.

• What storage conditions should I follow to ensure the Fetal Doppler maintains its performance?

  To maintain optimal performance, the Fetal Doppler devices should be stored according to the manufacturer’s guidelines, which are not detailed in the provided data but typically include protection from extreme temperatures, moisture, and physical damage. Since these devices are Class II medical devices, adhering to standard storage practices for ultrasound equipment—such as keeping them in a clean, dry environment and avoiding exposure to direct sunlight—is advisable. Always refer to the included instructions for the specific model.

• What is the primary clinical use of these Fetal Doppler devices, and how does it differ from other fetal monitoring tools?

  The Fetal Doppler devices are designed specifically for non-invasive, real-time monitoring of fetal heart rate during pregnancy, allowing clinicians to assess fetal well-being without invasive procedures. Unlike more advanced fetal monitors that provide continuous electronic recordings or additional parameters (e.g., heart rate variability), these handheld devices rely on Doppler ultrasound to convert blood flow signals into audible heartbeats. This makes them particularly useful in obstetric settings for quick, on-demand assessments, such as during prenatal check-ups or home use.

• How do I verify whether a particular Fetal Doppler model is compliant with both FDA and MDR regulations?

  The Fetal Doppler models listed (FD-231B, FD-231D, etc.) are explicitly noted as having received FDA 510(k) clearance and compliance with the Medical Device Regulation (MDR). The FDA clearance is confirmed by the presence of a 510(k) submission (K182526) and classification as a Class II device under FDA regulations. For MDR compliance, the device meets the requirements outlined in the MDR framework, ensuring it adheres to European Union standards for safety, performance, and regulatory oversight. Always check the device’s labeling or packaging for the specific regulatory markings.