FDA 510(k) Predicate Finder

A free, open-source tool to search FDA 510(k) clearances and identify potential predicate devices for medical device regulatory submissions.

🔍 Features

• Live API Search — Query the FDA's openFDA API in real-time
• Offline Mode — Load local database file for air-gapped environments
• Multi-Field Search — Search by device name, function, K-number, product code, applicant, or advisory committee
• Direct FDA Links — Click any K-number to view the official FDA record
• CSV Export — Download search results for further analysis
• No Registration — No account, no API key, no tracking

🚀 Quick Start

Option 1: Use Online (GitHub Pages)

Visit: https://rlwadh.github.io/fda-predicate-finder

Option 2: Download & Run Locally

1. Download index.html
2. Open in any modern browser
3. Start searching (Live API mode works immediately)

Option 3: Offline Mode

For environments without internet access:

1. Download the FDA 510(k) database from FDA
2. Open the tool and click OFFLINE FILE
3. Load your downloaded database file
4. Search completely offline

📊 Data Source

Data is retrieved from the openFDA Device 510(k) API, which contains 510(k) premarket notifications from 1976 to present.

🔎 Search Tips

• Product Code is the key for finding predicates — devices with the same code share intended use and regulatory classification
• Use the FDA Product Classification Database to find your product code
• Search by function (e.g., "blood glucose monitor") rather than brand names
• Filter by Advisory Committee to narrow results to your specialty area

🏢 About ADHOCON

ADHOCON GmbH is a medical device regulatory consulting company based in Ludwigshafen, Germany. We specialize in:

• EU MDR / IVDR compliance
• FDA 510(k) submissions
• Quality Management Systems (ISO 13485)
• Clinical Evaluation Reports
• Technical Documentation

Website: adhocon.com
Email: [email protected]

⚖️ Disclaimer

This tool is provided for informational purposes only and does not constitute regulatory, legal, or professional advice. The 510(k) data is sourced from the FDA's openFDA API and may not reflect the most current information. Users are responsible for independently verifying all information with official FDA sources before making regulatory decisions.

📄 License

MIT License — free for personal and commercial use.

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Made with ☕ by ADHOCON GmbH