FDA 510(k) Predicate
Finding & Analysis
Automatically identify and analyze predicate devices for your 510(k) submission. Our AI searches the complete FDA database, ranks candidates by substantial equivalence, and generates comprehensive comparison analysis to build your strongest SE argument.
What is Predicate Device Analysis?
Predicate device analysis is the foundation of your 510(k) submission. You must demonstrate substantial equivalence to a legally marketed predicate device—the right predicate choice determines your submission success.
Substantial Equivalence
Your device must be at least as safe and effective as a predicate device with the same intended use and similar technological characteristics.
FDA Database Search
Search thousands of cleared 510(k) devices in the FDA database to find candidates that match your device's classification and intended use.
AI-Powered Matching
Advanced AI analyzes intended use, technology, materials, performance, and regulatory history to identify the strongest predicate candidates.
How AI Predicate Finding Works
Our intelligent predicate analysis combines FDA database search with AI reasoning to deliver ranked, analyzed predicate candidates in minutes.
Classification-Based Search
Uses your confirmed device classification (product code, regulation) to search the FDA 510(k) database for devices with matching or similar product codes.
Shortlisted Code Extraction
AI extracts shortlisted product codes from classification results, identifying all potential device types that could serve as predicates.
Multi-Dimensional Analysis
For each candidate predicate, AI analyzes intended use alignment, technological characteristics, materials, design principles, performance specifications, and regulatory history.
Scoring and Ranking
Candidates are scored across multiple dimensions: intended use match, technology similarity, precedent strength, recency of clearance, and regulatory history. Results are ranked by substantial equivalence alignment.
Comparison Table Generation
Automatically generates detailed comparison tables showing side-by-side analysis of your device versus top predicate candidates across all key dimensions.
Recommendations and Justification
Provides primary and secondary predicate recommendations with clear justification. Identifies differences and provides rationale for why they don't raise new questions of safety or effectiveness.
Why Use AI-Powered Predicate Finding?
Manual predicate research takes weeks and requires deep FDA database expertise. AI predicate analysis delivers ranked, analyzed results in minutes.
10-30 Minutes, Not Weeks
Complete predicate analysis with ranked candidates, comparison tables, and SE justification in 10-30 minutes instead of weeks of manual research.
Intelligent Ranking
AI scores predicates across multiple dimensions to surface the strongest candidates first. Focus on predicates most likely to support successful SE demonstration.
Automated Comparison Tables
Generates comprehensive comparison tables covering intended use, technology, materials, performance, and regulatory history—ready for your SE narrative.
Primary & Secondary Predicates
Identifies primary predicate (most similar overall) and secondary predicates to justify specific features or characteristics.
Regulatory History Analysis
Reviews predicate device regulatory history, recalls, and safety signals to ensure you select predicates with clean regulatory records.
SE Justification Support
Identifies differences between your device and predicates, with AI-generated rationale for why differences don't raise new safety or effectiveness questions.
Complete Predicate Analysis Package
Get everything you need to build a strong substantial equivalence argument with comprehensive predicate analysis results.
Ranked Predicate Candidates
List of predicate devices ranked by substantial equivalence alignment, with scores and confidence levels for each candidate.
Detailed Comparison Tables
Side-by-side comparison tables covering intended use, indications, technology, materials, design, performance specifications, and more.
Difference Analysis
Identifies all differences between your device and predicates, with assessment of whether differences raise new safety or effectiveness questions.
SE Justification Rationale
AI-generated rationale explaining why identified differences don't impact safety or effectiveness, supporting your substantial equivalence claim.
510(k) Summary Links
Direct links to predicate device 510(k) summaries in FDA database, K-numbers, and manufacturer information for your reference.
Primary & Secondary Recommendations
Clear recommendations for primary predicate (best overall match) and secondary predicates to justify specific features or components.
Frequently Asked Questions
Common questions about predicate device finding and substantial equivalence analysis.
How does AI predicate finding work?
Cruxi's AI searches the complete FDA 510(k) database using your device classification and characteristics. The system analyzes candidate predicates based on intended use, technological similarities, regulatory history, and precedent matches. Results are ranked by substantial equivalence alignment with detailed comparison analysis.
Can I use multiple predicate devices in my 510(k)?
Yes. It's common to use a primary predicate (most similar overall) and secondary predicates to justify specific features. The AI analysis identifies both primary and secondary predicate candidates with clear justification for each. You must clearly identify each predicate and explain why each is appropriate for comparison.
What makes a good predicate device?
A good predicate must have: (1) Same intended use—non-negotiable requirement, (2) Similar technological characteristics—design, materials, energy sources, principles of operation, (3) Legally marketed status—cleared via 510(k), preamendment, or De Novo pathway, (4) Clean regulatory history—no significant recalls or safety issues.
How accurate are AI predicate recommendations?
AI predicate analysis provides ranked recommendations based on multi-dimensional scoring. However, final predicate selection should always involve human review, as strategic considerations (e.g., avoiding competitors' predicates) may influence choice. The AI provides evidence-based recommendations, but you make the final decision based on your regulatory strategy.
What if no suitable predicates are found?
If the AI analysis indicates no suitable predicates exist, this may signal that your device requires De Novo classification or PMA pathway. The system will flag this and recommend FDA Pre-Submission (Q-Sub) to discuss classification strategy with FDA before proceeding.
How long does predicate analysis take?
AI-powered predicate finding typically completes in 10-30 minutes. The system searches the FDA database, analyzes candidates, scores and ranks results, and generates comparison tables. Traditional manual predicate research can take weeks of regulatory affairs expert time.