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This summary of 510(k) safety and effectiveness information is being

This summary of 510(k) safety and effectiveness information is being 2025

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The document is a 510(k) summary for the KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor submitted by Andon Health Co., Ltd. It outlines the device's safety and effectiveness, intended use for measuring blood pressure and pulse rate non-invasively, and its substantial equivalence to the predicate device KD-7964. The KD-972 connects via Bluetooth to Apple devices for data display and adheres to various medical safety standards.

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What is a 510k summary or statement?

510(k) Summary or 510(k) Statement A 510(k) Summary is a condensed version of all the content of your 510(k). It will be made available to the public 30 days after your 510(k) is cleared, so be mindful of the details you include! The FDA website provides guidance on the content of your 510(k) summary.

What are 510k approval requirements?

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

What triggers a 510k?

Medical Devices must submit a 510k if the manufacturers plan to introduce a new device to the market. Additionally, the manufacturer must also submit an application if they plan to reintroduce a product that is significantly different from previous versions.

What are the requirements for 510k clearance?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

What is the 510k clearance process?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is 510k summary of safety and effectiveness?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act).

Which class generally requires 510 K clearance?

Manufacturers of Class II medical devices must receive 510k clearance from FDA before their product can be legally sold in the United States. 510k clearance is required for all non-exempt medical devices that fall into risk Class II.

What is the truthful and accuracy statement in 510k?

There are two such sections in the 510(k) that are templated by the FDA. These sections include: The Truthful and Accuracy Statement ensures that all information included is truthful and accurate and that nothing has been omitted.

This summary of 510(k) safety and effectiveness information is being 2025

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