top of page

THE 510K EXPERTS
  You make it. We clear it...

+1 386-243-4332

ABOUT 510K

 

Companies must file a 510(k) Premarket Notificaiton to receive FDA "approval" to market medium-risk medical devices. A 510(k) petition is a technical document. It is designed to demonstrate the product's safety and effectiveness...

ABOUT US

 

With a decade of experience, we help companies maneuver through FDA's complex medical device pathway.

 

We also help clients with other issues related to bringing those products to market...

FREE DOWNLOADS

 

As a public service, FDA 510k Consultants offers free charts that describe the regulatory process...

TIME IS MONEY!

Our goal at FDA 510k Consultants is to clear your medical device for the U.S. market in just four months... while also helping you save money. 

​

How can we do that? By focusing on FDA's Premarket Notification pathway. Instead of promising everytthing to everybody, we specialize in getting your product cleared fast--which is what you want.

​

Contact us for a free 30-minute consult.

TESTIMONIAL

"I was impressed with their determination to get our medical device cleared. Very good service. Couldn't have done it ourselves, not in this regulatory environment."

   Robert  L., Project Manager, USA

bottom of page