Atlas FDA

Your SE comparison, 80% assembled

Every 510(k) stands on a substantial-equivalence comparison table. Atlas pre-fills the record half - K-numbers, dates, review times, classes, regulations, recall checks - side by side with your device, and exports the scaffold your submission draft starts from.

1 · Collect candidates

On any clearance page, click Add to Predicate Builder. Up to eight, from any searches.

Start from a product code →

2 · Add your device

Name, intended use, technology, materials - your column sits beside the candidates, highlighted.

3 · Export the scaffold

One CSV: record rows pre-filled, judgment rows marked for your expertise, methodology footer included. Opens straight in Excel.

Free to build, free to try

The builder is included with every account; free accounts export 3 scaffolds a month. Open your builder or create an account.

What it will not do

The judgment rows - intended use, technological characteristics, materials of each predicate - come from 510(k) summaries and your professional analysis. Atlas fills what the record holds and stays honest about the rest; a tool that guessed those fields would be dangerous, not helpful.