510(k) Database Pro

Search the Complete FDA
510(k) Database.

Find predicate devices, track competitor clearances, and monitor real-time 510(k) decisions — all in one searchable interface built for regulatory professionals.

Access for $97/month

Cancel anytime. No long-term contracts.

Built for regulatory professionals

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Predicate Device Research

Search the full FDA 510(k) database by product code, applicant, device name, or decision date. Find the right predicate in minutes, not hours.

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Competitor Intelligence

Track competitor submissions and clearances in real time. Know when a new device enters your market before your competitors tell you.

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Real-Time Clearance Tracking

Get notified of new 510(k) clearances as they happen. Filter by product code, review panel, or third-party review status.

More than a search engine

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Complete FDA 510(k) database

Every 510(k) submission and decision, searchable and filterable

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Advanced filtering

Filter by product code, applicant, decision type, date range, and review panel

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Predicate chain mapping

Visualize predicate relationships to build your submission strategy

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Substantial equivalence analysis

Compare device characteristics across clearances for SE arguments

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Export and reporting

Download search results and generate reports for your regulatory submissions

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Daily database updates

New clearances and decisions added as soon as FDA publishes them