FDA 510(k) Submission for Medical Devices

FDA Medical Device Approval Process

See a flow chart that clearly explains the FDA 510(k) process step by step. Learn more about how the US FDA reviews 510(k) applications and how long it takes to obtain FDA approval (clearance).

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Does Your Device Require a 510(k)?

Want to know if your product requires a 510(k) submission? Learn how to determine your FDA device classification, Product Code, FDA Regulation Number and find predicate devices.

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Overview of FDA Review Fees and Costs

Overview of FDA fees for 510(k) application review and our costs to prepare a 510(k) for your device. We prepare all FDA 510(k) applications for a fixed fee so you know the final cost before begin.

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Sections of the FDA 510(k) Application

Learn more about the components of a 510 (k) application and whether they apply to your device, plus the different types of FDA 510(k) submissions: Traditional, Abbreviated and Special.

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Need FDA 510(k) clearance for a new medical device? Not sure if your product requires a 510(k)? We can help. Emergo Group prepares US FDA Premarket Notification applications for a wide range of medical products from surgical gloves (which require a 510k) to complex PACS imaging equipment. Our experience with thousands of medical devices means we help you obtain FDA 510(k) clearance quickly so you can start selling your medical device sooner. Read about why you should hire an experienced 510(k) consultant like Emergo Group to complete your submission to the FDA.

In addition to our FDA 510(k) “approval” consulting services, we offer a wide range of medical device QA and RA consulting services related to the US, Canada, Mexico, China, Japan, Europe, Russia and Australia.