Learn how to effectively use our platform to find the perfect predicate devices for your 510(k) submission
Welcome to the Predicate Device Search platform. This guide will help you navigate our tools and resources to find the most relevant predicate devices for your 510(k) submission. Finding the right predicate is crucial for a successful submission, and our platform streamlines this process.
Our platform provides powerful search capabilities that allow you to find devices by product code, applicant name, device name, and more. Use the search bar at the top of the homepage to start your search.
Access our extensive database of 510(k) cleared devices. Browse through thousands of medical devices and view detailed information about each one, including their predicates.
Visualize the relationships between devices and their predicates. Our relationship viewer helps you understand the lineage of devices and identify potential predicates.
Compare your device specifications with potential predicates using our analysis tools to find the most suitable matches for your 510(k) submission.
Begin by entering keywords related to your device in the search bar. You can search by device name, function, or technology.
Narrow down your search results using our advanced filters. Filter by product code, decision date, or applicant to find the most relevant devices.
Click on a device to view its detailed information, including its intended use, indications for use, and predicate devices.
Use our relationship viewer to see how devices are connected. This helps you identify the most suitable predicates for your submission.
Use our similarity analysis tools to compare your device specifications with potential predicates to find the best matches.
Use specific keywords related to your device's function, technology, or intended use to get more relevant results.
Recent clearances in your device category can provide valuable insights into current FDA expectations.
Always confirm that potential predicates have the same classification and regulation number as your device.
Sometimes a combination of predicates may be needed to support your device's technological characteristics and intended use.
A predicate device is a legally marketed device to which a new device can claim substantial equivalence. Finding the right predicate is crucial for a successful 510(k) submission.
The best predicate device is one that has the same intended use and similar technological characteristics as your device. Our platform helps you identify potential predicates based on these factors.
Yes, you can use multiple predicates in your submission. This is often necessary when no single device shares both the intended use and technological characteristics of your device.
Our database is updated regularly to include the latest FDA 510(k) clearances. You can check the 'Recent Clearances' section on our homepage to see the most recent additions.
Official guidelines from the FDA on the 510(k) submission process.
Learn MoreDetailed video tutorials on how to use our platform effectively.
Learn MoreExamples of successful 510(k) submissions to help guide your process.
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