Class I, II, or III?
Get a defensible answer in minutes.
Complizen analyzes your intended use and device characteristics, queries the FDA classification database, surfaces comparable cleared devices, and outputs a classification rationale document — cited and ready to defend to investors, FDA, and your quality system.
From device description to classification rationale in four steps.
Describe your device
Provide your intended use, patient population, and technological characteristics. Plain English — no regulatory jargon required.
Complizen searches
Superagent queries the FDA classification database, 510(k) history, and any relevant De Novo decisions simultaneously.
Review the output
Device class, product code, 21 CFR regulation, applicable special controls, user fee, and pathway — all with direct citations.
Export the rationale
A classification rationale document, formatted for your quality system or investor deck — ready in minutes, not weeks.
Not just a class number. A full rationale document.
Every classification Complizen produces comes with the supporting evidence — not just the answer, but the reasoning FDA and investors need to see.
- Device class (I, II, or III) with 21 CFR citation
- Product code and regulation number
- Applicable special controls with source links
- Submission pathway (510(k), De Novo, PMA, Exempt)
- Current FDA user fee for selected pathway
- Comparable cleared devices for context
- Exportable classification rationale document
“We had our classification and regulatory pathway mapped within hours of getting started. Work that used to feel like the hardest part of the whole process suddenly wasn't.”
