510k Medical Device Registration

Get 510 (K) medical devices registered with assistance from an FDA expert at Quality Smart Solutions. We help you by reviewing the requirements to ensure your device meets FDA safety and efficacy standards for premarket submission. 

What is 510k?

A 510(k) is a Premarket Notification for medical devices submitted to the FDA. It’s  premarket submission to Food and Drug Administration (FDA) to demonstrate that the device is as safe and effective for human use as the legally marketed device that is not subjected to Pre-market Approval (PMA). The reason why a particular medical device is 510(k) is that 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act). 

Medical Devices FDA 510k Clearance

If you want to market Class I, Class II, and Class III devices in the US market for which a Premarket Approval application (PMA) is not required, you must submit US FDA 510 (k). Most of the Class I devices are excluded from 510k requirements.  If the authority finds, during the review of the 510k file, that the device is Substantially Equivalent (SE), it will give clearance with a ‘k’ number. Meeting SE proves that the medical device is as safe and effective as the predicate device (legally marketed device in the USA).

Timelines for FDA review of 510(k) submissions

The length of time FDA 510(k) reviews can vary from 3 to over 12 months.  This depends on whether additional information (AI) letter is issued by FDA or if a Refuse to Accept (RTA) is issued.   The complexity of the device (typically higher class devices are more complex and have more data than lower class devices) can also contribute to this timeline.  FDA’s service standard is set at 90 calendar days. However, whenever an AI letter is issued the review “clock” is paused until there is an answer.  Up to 180 calendar days is given to respond to the AI.  So, if the maximum time is taken to respond to each AI it can take a very long time to get final clearance from FDA.  It’s imperative that responses happen quickly so the clock resumes.  

510(k) Medical Device Registration at Quality Smart Solutions

Make 510(k) Medical Device Registration convenient and hassle-free with the help of former FDA officials at Quality Smart Solutions. We offer quality support to businesses in getting 510 K medical devices registered. We help:

Determine FDA Clearance

Determine which predicate (similar) device already has FDA 510(K) clearance and whether it is suited for 510(k) submission.

Review Testing Requirements

Get help from our professionals in reviewing testing requirements, applicable FDA guidelines and documents and standards.

Product-Specific List

Get a detailed product-specific list of documents required for review from our FDA 510(k) consulting professionals.

List of Documents & Reports

We prepare and provide a complete list of reports, documents, diagrams or clinical data before 510(k) preparation begins.

Technical Comparison

With us, you can easily prepare a technical comparison of your medical device to other devices with FDA 510 (k) Clearance.

Interaction with Agency

We interact with agencies during 510(k) Medical Device Registration process to get your medical devices registered.

Register Your 510(k) Medical Device Today!

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