Welcome to SittuAI Your Autonomous Regulatory AI Agent
Not another chatbot. SittuAI is an autonomous AI agent purpose-built for FDA 510(k) submissions — handling predicate analysis, document generation, and compliance validation end-to-end. Months of regulatory work, compressed into days.
What Your AI Agent Does
Purpose-built AI grounded in 500K+ FDA predicate records, 21 CFR Part 820, and current FDA guidance
Predicate Intelligence
Instantly finds and analyzes similar cleared devices from our comprehensive FDA database.
SittuAI Chat
Ask anything about your submission. Get precise, FDA-grounded answers anchored to your device profile and 510(k) precedents — not generic AI responses.
AI Document Generation
Automatically generates 24+ compliant regulatory documents tailored to your device profile and FDA requirements.
Knowledge Graph
Connected intelligence that understands device relationships, regulations, and FDA guidance documents.
Compliance Validation
Real-time validation against 21 CFR requirements and current FDA guidance documents.
Simple 4-Step Process
From device profile to FDA-ready submission package
Define Your Device
7-step guided wizard
AI Analysis
Find predicates & gaps
Generate Documents
24+ docs auto-drafted
Export Package
eSTAR-ready format
From Device Profile to FDA-Ready Submission
A purpose-built platform that guides medical device companies through every step of the 510(k) journey — intelligently, efficiently, and with confidence.
Intelligent Device Setup
Get started in minutes with our guided 7-step device onboarding wizard. Define your device's intended use, classification, target users, and predicate strategy. Our AI builds a rich Device Knowledge Graph that powers every downstream workflow — from document generation to predicate matching.
Structured Regulatory Workflow
Follow a proven, stage-gated submission workflow built around FDA expectations. SittuAI breaks the 510(k) journey into clear phases so your team always knows what's next, what's pending, and what's complete — with full progress visibility across every stage.
AI-Powered Document Generation
Generate all 24+ regulatory documents from a single device profile. Each document comes with section-level tracking, individual approval workflows, and AI-assisted content generation per section — so your team can review, edit, and approve with precision rather than starting from scratch.
SittuAI Chat
Ask anything. Get precise, grounded answers. SittuAI Chat is trained on FDA guidance documents, 510(k) precedents, and your device's own knowledge graph — delivering consistent, reliable answers specific to your submission rather than generic AI responses.
The SittuAI Advantage
Unlike generic AI tools, SittuAI is purpose-built for FDA 510(k) submissions. Every feature — from predicate intelligence to document assembly — is designed around real regulatory workflows. The result: up to 60% faster submission preparation, fewer revision cycles, and teams that spend time on strategy, not paperwork.
Ready to Transform Your 510(k) Submission?
Join medical device companies who are submitting faster, smarter, and with confidence.
Grow your consulting practice — without growing the grind.
80% of your time is spent on documentation, not expertise. SittuAI handles the drafting work so you can focus on what clients actually pay you for: validation, strategy, and FDA know-how. Join our platform for free and get matched with medical device companies who need your expertise.
Serve more clients, faster
AI drafts the documents needed per submission. You validate, not rewrite. Take on 3-5× more clients in the same time.
Get matched with new customers
Medical device, Pharma & Cosmetic companies and SaMD startups come to us for help. We route qualified clients directly to consultants on our platform.
Free to join.
No subscription, no platform fees. Use SittuAI's AI-powered Predicate Matching & Co Pilot chat for your own client engagements.
Cut submission time in half
Validated by a working FDA consultant: 60% reduction in total 510(k) submission time. Deliver faster, impress clients, win more repeat business.
Your expertise stays yours
You validate every document. Your name, your credentials, your sign-off. SittuAI is the leverage — you're still the expert.
510(k), De Novo, PMA ready
Pre-built workflow templates for every major FDA submission pathway. Knowledge graph built from FDA regulations, guidance, and real precedents.
Takes 2 minutes. We'll be in touch within 1 business day.
Latest FDA Regulatory Insights
Expert-written guides on 510(k), De Novo, PMA submissions, and compliance strategy.
Predetermined Change Control Plans (PCCP) for AI/ML Medical Devices: An Interpretive Guide
**Summary:** The FDA's December 2024 PCCP guidance allows AI/ML medical device makers to pre-approve post-market algorithm changes without new submissions, provided they submit detailed plans describing anticipated modifications, implementation methods, and performance standards. Common deficiencies include vague change descriptions, inadequate performance metrics, and insufficient risk documentation.
Device Modifications and the 510(k) Threshold: When You Need a New Clearance
**Summary:** Medical device manufacturers must submit a new 510(k) when modifications—firmware updates, material changes, label updates—could significantly affect safety or effectiveness. FDA enforcement includes warning letters, recalls, and product seizures for unauthorized changes.
Handling FDA Additional Information Requests (AI Requests) in 510(k) Submissions
AI requests pause 510(k) review timelines until complete responses are submitted, and submissions requiring multiple AI cycles average 200+ FDA days—double the standard review goal. Understanding what triggers AI requests (missing data, performance testing gaps, software deficiencies, biocompatibility issues) and crafting thorough, well-organized responses is critical to avoiding delays and NSE decisions.
Ready to Transform Your Regulatory Submissions?
Join leading medical device companies who have reduced their 510(k) preparation time by 60%.