510(k) Clearance.
Prepare, validate, and submit your FDA 510(k) using our eStar-compliant platform. We guide you from Predicate selection to Substantial Equivalence.
Substantial Equivalence.
Every 510(k) hinges on a “Predicate Device” (a legally marketed device). We help you search the FDA database to find the perfect match in terms of Intended Use and Technology.
Class I, II, or III?
Most Class I devices are exempt. Class III need a PMA. 510(k) is for Class II. We verify your Product Code (3 letters) to confirm your regulatory pathway.
Testing Requirements.
FDA wants data. Biocompatibility (ISO 10993), Electrical Safety (IEC 60601), and Sterilization (ISO 11135). We map out exactly which tests your device needs.
The eStar Revolution.
The “electronic Submission Template And Resource” (eStar) is now mandatory. It's a complex, interactive PDF. Our platform fills it out for you, preventing RTA (Refuse to Accept) errors.
Software as Medical Device.
Building an App or AI algorithm? SaMD has unique requirements: Cybersecurity (patch management), Interoperability, and Software Validation (IEC 62304).
User Fee Optimization.
The standard 510(k) fee is high ($21k+). But if you have gross receipts under $100M, you qualify for the Small Business rate (75% off). We help you file the qualification.
90-Day Review.
FDA has 90 days to review your submission. But “Hold” times for Additional Information (AI) don't count. We optimize your submission to minimize stops and starts.
Platform vs. Consultants.
Traditional regulatory consultants charge $20k-$50k. We use technology to lower the cost.
Get Cleared Faster.
Stop paying for hours. Pay for clearance.
Full Clearance Support
From concept to commercialization, we handle the regulatory burden.
Pre-Sub Meetings
Strategy sessions with FDA (Q-Submission).
eCopy Creation
Formatting valid eCopies for the document center.
Post-Market
Transitioning to listing and UDI after clearance.
Frequently Asked Questions
Common questions about this regulatory requirement.
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