Guest post by Lisa Voronkova, Founder & CEO of OVA Solutions and author of the "Hardware Bible."
Follow Lisa's free newsletter here - https://meddev.beehiiv.com
Every founder building a medical device googles "510(k) cost" at some point. If you are new to this: a 510(k) is the most common FDA pathway for getting a medical device cleared for sale in the US. You demonstrate that your device is substantially equivalent to something already on the market (a predicate device), and the FDA lets you sell it. About 3,000 of these clear every year.
What you find when you google the cost is a range so wide it is useless: "$5,000 to $500,000." That is like saying a car costs between $2,000 and $200,000. Technically correct, practically worthless.
Here is the breakdown with real numbers for 2026.
1. The FDA User Fees
Before you write a single page of the submission, you have to pay to play.
Standard 510(k) Fee (FY 2026): $26,067
Small Business Fee: $6,517 (Requires <$100M gross receipts and an approved Small Business Determination).
Annual Establishment Registration Fee: $11,423 (No small business discount).
Total Entry Cost: Roughly $18,000 to $37,000 in mandatory government fe...
