About FDA 510k Consultants, LLC

Every day, our small, focused, U.S.A. based regulatory consulting firm prepares, submits, and shepherds 510(k) Premarket Notifications through the U.S. Food & Drug Administration (FDA). Currently, we have offices in South Florida and Washington, D.C. We cater to small businesses that manufacture or import medical devices for the American market. Also, we consult and assist foreign companies with regulatory staffs that prefer we handle the tricky 510(k) clearance pathway.

From North and South America to Europe and Asia, our clients span the globe. From newcomers to seasoned pros with broad CE Mark experience, they bring us a wide range of background in regulatory wisdom.

Meet our expert team

John F. Gillespy standing in front of the entrance sign at FDA headquarters, in Silver Spring, Maryland
Once a quarter, John Gillespy visits 510(k) reviewers at FDA Headquarters in Silver Spring, MD

John F. Gillespy, M.B.A. President and C.E.O.

John began his career as a C.P.A., with the international accounting firm, PricewaterhouseCoopers. Later he spent some years with two Fortune 50 firms, including IBM Corp. Then he discovered an enduring passion for small business. Eventually, he embraced the entrepreneur’s life and continues his success today.

John’s experience in small business began in the investment-capital markets. First he served as C.F.O. of a boutique investment banking 1980s startup. Partners and he co-founded a related venture, through the early 1990s. Around this time, John founded a multi-location, multi-tenant property-management company, and ran it for 14 years. During the Great Recession, real estate took a blow.

In the recession’s wake, John sought work in the dental imaging industry. Quickly, he found an interesting niche, and co-founded an FDA 510(k) consulting business. After growth and further development within that business, John took his experience into the present company, FDA 510k Consultants, LLC.

John’s academic credentials include

  • a B.A. in Economics from Duke University;
  • a B.B.A. in Accounting from Stetson University; and
  • an M.B.A. in Finance and Marketing from Duke’s Fuqua School of Business, where he was a Fuqua Scholar.

John’s philosophy is to deliver top-shelf service at an affordable price.

John transforms the 510(k) pathway, by his focus on a niche — in new medical devices — within the regulatory space. As he continues his years-long dedication toward transparency into the industry’s pricing practices, the stakes continue to rise.

Let’s meet

“We’re good at what we do because that’s all we do — clear medical devices for sale in the United States through the complex 510(k) Premarket Notification pathway. Time is money. Why lose months getting new products to market? Hire the team that enjoys helping your company grow. Call or contact us today! The initial consultation is free.

John F. Gillespy, President and C.E.O., FDA 510k Consultants, LLC