The Intelligent Path to
FDA 510(k) Clearance.
Replace regulatory uncertainty with AI-driven strategy. Cruxi analyzes your device, identifies risks, and drafts a compliant, submission-ready 510(k) to accelerate your clearance with confidence.
Start your Regulatory Assessment for free.
From Regulatory Burden to Strategic Advantage
The traditional 510(k) process is a maze of documentation and regulatory risk. Cruxi provides an intelligent, structured platform to ensure a clear and efficient path to clearance.
Overcome Regulatory Uncertainty
Stop guessing. Our AI analyzes your device against FDA guidelines to create a precise regulatory roadmap, identifying testing requirements and potential hurdles upfront.
Prevent Costly Delays
Our platform is built on the official eSTAR template, enforcing compliance and drastically reducing the administrative errors that lead to RTA deficiencies and FDA questions.
Empower Your Team with AI
Free your regulatory experts from tedious paperwork. Cruxi handles the low-value drafting and research, allowing your team to focus on high-impact strategy and review.
Your End-to-End Regulatory Intelligence Platform
Cruxi's structured workflow guides you from initial concept to a final, submission-ready eSTAR package, ensuring compliance at every step.
1. Centralized Knowledge Ingestion
Securely upload all your project files—PDFs, Word docs, test data, images. Our Universal Ingestion Engine extracts and indexes everything into a single, queryable knowledge hub for your project.
2. AI Regulatory Assessment
Answer a guided questionnaire and our AI performs a comprehensive assessment, determining your device class, regulatory pathway, and generating a personalized checklist of submission requirements.
3. Intelligent Predicate Analysis
Based on the assessment, our AI searches the FDA database and ranks the most viable predicate devices, helping you build the strongest possible substantial equivalence argument.
4. AI Advisor & Risk Analysis
Our most powerful feature. The AI simulates an FDA reviewer's perspective on your submission, providing a clearance success probability and identifying critical gaps *before* you submit.
5. Compliant AI Drafting
Generate precise, compliant drafts for any section of your 510(k). The AI uses only your centralized data, ensuring every statement is consistent, accurate, and traceable back to a source document.
6. eSTAR Assembly & Export
Review and finalize all sections within our eSTAR-aligned workspace. When ready, export a complete, submission-ready package that meets the FDA's electronic submission requirements.
A Unified Workspace for Submission Excellence
Manage your entire 510(k) in a single, collaborative environment where data, drafts, and compliance live together.
The New Standard for Regulatory Strategy
"The AI Advisor Analysis was a revelation. It flagged two major gaps in our testing strategy that our consultant missed. Cruxi didn't just speed up our submission; it made it stronger."
- Sarah L., Head of Regulatory Affairs
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"Cruxi transformed our regulatory process from a reactive chore into a proactive strategy. The ability to build a submission from a single source of truth saved us from countless consistency errors and accelerated our path to clearance."
- Dr. Ben Carter, CEO & Founder
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A Comprehensive 510(k) Resource Hub
Navigate the complexities of FDA submissions with our expert guides and checklists. Built to support your journey from concept to clearance.
The Ultimate 510(k) Checklist
Our comprehensive, step-by-step checklist ensures you cover every required document and data point for a successful submission. Avoid common pitfalls and RTA holds.
View the Checklist →Mastering the eSTAR Template
A detailed guide to the FDA's mandatory electronic submission template. Learn how to navigate its structure and leverage our software to automate its completion.
Read the eSTAR Guide →Predicate Device Analysis
Learn the strategy behind selecting the right predicate device and constructing a compelling substantial equivalence argument—the core of any successful 510(k).
Learn Predicate Strategy →Ready to De-Risk Your Path to Market?
Build your next 510(k) with the strategic advantage of AI. Start your free regulatory assessment and see the clear path to your FDA clearance.
Start Your Intelligent 510(k)