Medical Device Establishment Registration and Listing for Class 1 and 510k cleared devices
FDA 510k Overview
FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective as legally marketed devices that are not subjected to PMA. Organizations planning to launch Class I, II, and III medical devices in the United States intended for human use must submit a 510k if pre-market approval is not required.
Most class 1 medical devices are exempt from 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the 510k clearance with a ‘(k)’ number. We offer technical and scientific assistance in identifying a suitable predicate device, regulation number, and device code, along with 510k drafting, e-copy conversion, and FDA submission through US Agent service. Few manufacturers opt for Q-Submission before final submission.
Why Choose US for FDA 510k Clearance?
With an impressive 85% success rate, a track record of over 350 plus 510(k) clearances worldwide, and a history of serving more than 150 plus manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.
Types of FDA 510k's
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Special FDA 510k
This 510k submission is for an already cleared device with some changes that don’t require the full review but only the summary document.
These changes include indications of use, design, and labelling, but they should not affect the safety or performance of the new, modified device, and well-established methods can be used to evaluate the changes.
Every FDA 510k file is scrutinized by FDA reviewers for substantial equivalence determination.
You need support to reach FDA 510k clearance fast. That’s where we come in. To know more, check out this video to see how our services fit for your business! For any questions, contact us.
As a prominent 510k consulting organisation on a global scale, we have gained the trust of more than 350 plus manufacturers and specification developers. Our team consists of highly skilled subject-matter experts, assuring timely 510k clearance irrespective of the manufacturer's size or the regulatory knowledge of their internal team. Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete FDA 510k file on behalf of our clients and take full responsibility until the 510k clearance is obtained.