Fetal Ultrasonic Monitor and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131457 FDA 510(k)
- FDA Product Code
- KNG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2660 FDA 510(k)
- Regulation Number
- 884.2660 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Fetal Ultrasonic Monitor, classified under the nomenclature for diagnostic ultrasound systems used to evaluate fetal health. It employs ultrasound technology to generate real-time images of the fetus, placenta, and amniotic fluid, enabling assessment of gestational age, fetal development, and potential abnormalities during pregnancy. The system is designed for obstetric applications, providing critical diagnostic information to healthcare providers.
The Fetal Ultrasonic Monitor is supplied as a reusable medical device, intended for use in clinical settings such as hospitals and obstetric clinics. It operates under regulatory authorisations including FDA 510K clearance and MDR compliance, adhering to standards for diagnostic ultrasound equipment. The device includes multiple accessory parts, each identified by unique reference codes (e.g., 3030151584, 3003971136), ensuring compatibility and functionality. Storage and handling follow standard medical device protocols to maintain performance and sterility where applicable.
Frequently asked questions
Is this fetal ultrasonic monitor designed for single-use or can it be reused in clinical settings?
This fetal ultrasonic monitor is explicitly described as a reusable medical device, intended for use in clinical settings like hospitals and obstetric clinics. Since it is classified as a reusable diagnostic ultrasound system, proper cleaning, maintenance, and storage protocols must be followed to ensure performance, safety, and compliance with regulatory standards.
What regulatory pathways has this device undergone, and how does that affect its use in clinical practice?
The device has been cleared via the FDA 510(k) pathway (traditional route, classified as substantially equivalent) and complies with MDR (Medical Device Regulation) standards. This means it has undergone FDA review by the Obstetrics/Gynecology (OB) advisory committee and is authorized for obstetric diagnostic imaging. Clinicians can rely on its compliance with U.S. and EU regulatory frameworks for obstetric ultrasound applications.
Does this device come with accessories, and if so, how are they identified or referenced?
Yes, the fetal ultrasonic monitor includes multiple accessory parts, each with a unique FEI number (e.g., 3030151584, 3003971136) and registration number (e.g., 3030151584). These identifiers ensure compatibility and proper pairing with the main device. The accessories are part of the system’s design and must be used together for intended diagnostic functionality.
How should this device be stored to maintain its performance and integrity?
While the device description does not specify exact storage conditions, as a reusable medical device, it must follow standard protocols for cleanliness, calibration, and environmental protection to prevent contamination or damage. Since it is not explicitly labeled as sterile, clinicians should adhere to manufacturer guidelines (likely provided in accompanying documentation) for proper storage, handling, and maintenance to ensure reliable operation.
What types of diagnostic assessments can this device support during pregnancy?
This fetal ultrasonic monitor uses ultrasound technology to generate real-time images of the fetus, placenta, and amniotic fluid, enabling assessments of gestational age, fetal development, and potential abnormalities. It is specifically designed for obstetric applications, providing critical diagnostic information to healthcare providers during pregnancy monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131457 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K131457 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026