A year and $140K for FDA clearance. What I'd tell myself on day one.

I'm a solo founder. I make an LED light therapy mask, and I decided early that I wanted FDA 510(k) clearance rather than selling it as a generic beauty gadget. Most competitors under $400 don't have it, which tells you something about how painful the process is.

Twelve months. Roughly $140K. One person.

The single most expensive mistake I made was assuming a testing lab is a testing lab.

I picked one based on price and turnaround. Their reports looked professional. What I didn't check was whether their accreditation actually covered the specific standards my submission needed. It didn't. The data was unusable, and I had to run the testing again somewhere else — months gone, and a large chunk of that $140K was just paying twice for the same tests.

What I'd do differently:

Ask for the lab's ISO 17025 scope document before you pay anything. Not their certificate — the scope. It lists exactly which standards they're accredited to test against. If the standard your device needs isn't on that list, walk away, no matter how good the quote is.

Pick your predicate device before you design anything. Your whole submission is an argument that your product is substantially equivalent to something already cleared. If you design first and go looking for a predicate afterward, you've made your own life much harder.

Budget in calendar time, not just money. The money is knowable. The delays are not, and for a one-person company, twelve months of runway with no revenue is the part that actually kills you.

Happy to answer anything specific — it's a process almost nobody documents publicly, and I would have paid real money for a post like this a year ago.