How much does a 510(k) cost?

In short: Industry-cited figures for preparing a first 510(k) run from the low tens of thousands of USD for a simple software 510(k) with a strong predicate, up to roughly USD 150,000–350,000 for complex, consulting-heavy submissions — on top of FDA user fees (reduced for qualifying small businesses). Testing — bench, software V&V, cybersecurity — is usually the largest variable. Figures are industry-cited ranges, not quotes.

Where the money actually goes

The USD 150,000–350,000 range describes complex, consulting-heavy first submissions; a simpler software 510(k) with a well-matched predicate and limited fresh testing can land well below it, with industry-cited figures starting in the low tens of thousands. Wherever you sit on that span, the budget covers regulatory strategy and consulting, predicate research, documentation preparation, and testing — but testing is usually the single largest and most variable line item within it. Software verification and validation, cybersecurity testing (increasingly non-negotiable since FDA's Section 524B requirements), and any bench or clinical testing specific to your device type can range from modest to a large share of the total budget, depending on how novel your technology is and how much testing your predicate comparison already covers versus what you need to generate fresh.

FDA user fees are separate, and change every year

On top of preparation costs, FDA charges a user fee to file a 510(k), set annually and published in FDA's fee schedule — check the current year's figure directly rather than relying on a cited number, since it changes yearly. Qualifying small businesses can apply for a substantially reduced fee, which is worth confirming eligibility for early, since the qualification process itself takes some lead time.

What actually moves the number

Predicate fit again does real work here: a strong predicate match can reduce the testing burden significantly, since well-matched technological characteristics reduce how much new evidence you need to generate. A first-time submitter with no in-house regulatory experience typically sits toward the higher end of whichever bracket fits their device, since external consulting fills gaps a more experienced team would cover internally. Budgeting conservatively for a genuinely first 510(k), and revising downward once real testing and consulting quotes are in hand, is a more realistic planning approach than anchoring to the low end. One framing note: these are submission costs — staying compliant afterwards (annual establishment registration fees, maintaining your quality system, post-market obligations) is a separate, ongoing budget line.

Where next: Why Most 510(k)s Get an Information Request · How long does a 510(k) really take?

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