Find your best 510(k) predicate — smart, fast and thoroughly
Cut hours of manual research. Let Smart Predicate surface the strongest matches for your submission with speed and precision.
Find your best 510(k) predicate — smart, fast and thoroughly
Cut hours of manual research. Let Smart Predicate surface the strongest matches for your submission with speed and precision.
Find your best 510(k) predicate — smart, fast and thoroughly
Cut hours of manual research. Let Smart Predicate surface the strongest matches for your submission with speed and precision.
KEY BENEFITS
Why Smart Predicate?
Designed for regulatory teams, Smart Predicate bridges the gap between unstructured FDA data and confident decision-making.
Smart Match
Describe your device's indications of use and technical characteristics naturally. Receive predicate matches based on functionality, not just keywords.
Side-by-Side Comparison
Evaluate potential predicates with standardized data to quickly identify your strongest options for submission.
Landscape Analytics
Visualize the device landscape to understand market positioning and identify strategic opportunities.
Export & Documentation
Generate share-ready reports with properly formatted references to streamline the preparation of regulatory documentation.
Time-Saving Automation
Replace days of manual database searches with minutes of intelligent matching, reducing predicate search time by up to 75%.
KEY BENEFITS
Why Smart Predicate?
Smart Match
Describe your device's indications of use and technical characteristics naturally. Receive predicate matches based on functionality, not just keywords.
Side-by-Side Comparison
Evaluate potential predicates with standardized data to quickly identify your strongest options for submission.
Landscape Analytics
Visualize the device landscape to understand market positioning and identify strategic opportunities.
Export & Documentation
Generate share-ready reports with properly formatted references to streamline the preparation of regulatory documentation.
Time-Saving Automation
Replace days of manual database searches with minutes of intelligent matching, reducing predicate search time by up to 75%.
KEY BENEFITS
Why Smart Predicate?
Designed for regulatory teams, Smart Predicate bridges the gap between unstructured FDA data and confident decision-making.
Smart Match
Describe your device's indications of use and technical characteristics naturally. Receive predicate matches based on functionality, not just keywords.
Side-by-Side Comparison
Evaluate potential predicates with standardized data to quickly identify your strongest options for submission.
Landscape Analytics
Visualize the device landscape to understand market positioning and identify strategic opportunities.
Export & Documentation
Generate share-ready reports with properly formatted references to streamline the preparation of regulatory documentation.
Time-Saving Automation
Replace days of manual database searches with minutes of intelligent matching, reducing predicate search time by up to 75%.
AI-POWERED
Built on Machine Learning. Tuned for Regulatory Context.
Smart Predicate is powered by RegHero's in-house Machine Learning pipelines that extract, structure, and connect insights across FDA datasets — helping your team make faster, smarter regulatory decisions.
AI-POWERED
Built on Machine Learning. Tuned for Regulatory Context.
Data Extraction & Structuring
Pulls key details from FDA documents and formats them into structured, searchable data.
Data Extraction & Structuring
Pulls key details from FDA documents and formats them into structured, searchable data.
Data Extraction & Structuring
Pulls key details from FDA documents and formats them into structured, searchable data.
Smart Predicate Search
Finds relevant predicates using AI that understands device function—not just keywords.
Smart Predicate Search
Finds relevant predicates using AI that understands device function—not just keywords.
Smart Predicate Search
Finds relevant predicates using AI that understands device function—not just keywords.
Predicate Network Mapping
Visualizes how devices relate across FDA filings to uncover patterns and gaps.
Predicate Network Mapping
Visualizes how devices relate across FDA filings to uncover patterns and gaps.
Predicate Network Mapping
Visualizes how devices relate across FDA filings to uncover patterns and gaps.
Impact
Real results for real teams
Smart Predicate doesn't just improve search — it transforms workflows and saves teams hours per submission.
75%
Reduction in predicate search time
40%
More relevant predicates discovered
170k+
FDA-cleared devices indexed
4×
faster submission preparation
Impact
Real results for real teams
75%
Reduction in predicate search time
40%
More relevant predicates discovered
170k+
FDA-cleared devices indexed
4×
faster submission preparation
Impact
Real results for real teams
Smart Predicate doesn't just improve search — it transforms workflows and saves teams hours per submission.
75%
Reduction in predicate search time
40%
More relevant predicates discovered
170k+
FDA-cleared devices indexed
4×
faster submission preparation
Try Smart Predicate — Free
Experience smarter predicate search today. No credit card required.
Try Smart Predicate — Free
Experience smarter predicate search today. No credit card required.
Try Smart Predicate — Free
Experience smarter predicate search today. No credit card required.
Whether you're launching a new Class II device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.
Whether you're launching a new Class II device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.
Whether you're launching a new Class II device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.