Predicate QuickCompare

Compare up to 3 cleared 510(k) devices side-by-side with automated substantial equivalence analysis. This free tool saves consultants 4-6 hours per comparison by generating comparison tables, SE bullets, and difference justifications automatically.

How It Works

Predicate QuickCompare automates the predicate comparison process:

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Multi-Device Comparison: Enter up to 3 predicate device K numbers or device names, and the tool automatically retrieves device information from FDA databases including 510(k) summaries, product codes, and clearance dates.
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Side-by-Side Analysis: Generates comprehensive comparison tables covering intended use, technological characteristics, materials, design features, performance specifications, and labeling.
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Substantial Equivalence Bullets: Automatically generates SE bullets highlighting similarities and differences between predicates, formatted for inclusion in 510(k) submissions.
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Difference Justification Framework: Identifies key differences between predicates and provides templates for justifying how differences don't raise new questions of safety or effectiveness.
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Regulatory History Check: Verifies that predicates are legally marketed, not recalled, and have clean regulatory histories suitable for use as predicates.

What It Does

This tool generates comprehensive predicate comparison reports:

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Comparison Tables: Detailed side-by-side tables comparing all critical device characteristics across multiple predicates
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SE Analysis: Substantial equivalence bullets formatted for FDA submission, highlighting similarities and differences
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Predicate Suitability Assessment: Evaluation of which predicate(s) are most suitable based on intended use and technological similarity
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Difference Justification Guide: Framework for justifying differences between predicates and your device, with regulatory guidance citations
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Exportable Report: Professional PDF comparison report with your branding that can be included in 510(k) submissions or shared with clients

⏱️ How It Saves Time

Saves 4-6 hours per comparison by automating predicate analysis:

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Automated Data Retrieval: Eliminates 1-2 hours of manually searching FDA databases and downloading 510(k) summaries for multiple predicates
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Comparison Table Generation: Saves 2-3 hours of manually creating side-by-side comparison tables across dozens of device characteristics
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SE Bullet Drafting: Automates 1-2 hours of writing substantial equivalence bullets and formatting them for FDA submission
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Consistent Formatting: Ensures all comparisons follow FDA formatting requirements, reducing review time and potential RTA issues

ROI: for FDA 510k Consultants performing 5+ predicate comparisons per month, this tool saves 20-30 hours monthly while improving analysis quality.

Perfect For

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FDA 510k consultants evaluating multiple predicate options for client devices
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Regulatory teams preparing substantial equivalence sections for 510(k) submissions
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Firms providing predicate analysis services to medical device companies
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FDA 510k consultants reviewing and validating client-provided predicate comparisons

Need help with predicate strategy?

If you want expert support on predicate selection or SE strategy, compare providers in the Cruxi directories hub.

Get Free Access to Predicate QuickCompare

This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

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✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding