FDA 510(k)

K241524—Elucid PlaqueIQLLZOHT8 · Radiology

accessdata.fda.gov

Regulatory Intelligence for SaMD

Know your FDA path
before you build your
company around
the wrong one.

PROTOCOL classifies your device, identifies relevant predicates, surfaces evidence expectations, and maps the regulatory path ahead — in minutes, not months.

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Live Intelligence Preview

This is what PROTOCOL surfaces — for any medical AI device.

Sample deviceCoronary CT AI (CCTA plaque analysis)

Classification

Product CodeLLZ

Pathway510(k) Traditional

Review DivisionOHT8 · Radiological Health

● Source: FDA accessdata.fda.gov

Primary Predicate

K241524 — Elucid PlaqueIQ

Cleared via 510(k) · FDA accessdata.fda.gov

SourceFDA accessdata

Verified✓ FDA-verified source data

Likely FDA Focus Areas

Q1Demonstrate plaque quantification accuracy vs expert reader ground truth

Q2Address algorithm performance across CCTA scanner types and protocols

Q3Confirm output is quantitative aid only — clinical decisions with cardiologist

⚠ AI-derivednot verbatim FDA language

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What PROTOCOL gives you

Know your path. Know your evidence.
Build your submission.

KNOW YOUR PATH

Know your regulatory path before you build around the wrong one.

›510(k) or De Novo — based on device classification and predicate analysis
›Timeline and cost estimate by FDA division
›Performance bar derived from predicate clearances
›Pre-Sub strategy and FDA engagement timing

KNOW YOUR EVIDENCE

See every device that got cleared before yours.

›Predicate analysis from FDA 510(k) database
›Anticipated reviewer focus areas from similar clearances
›MAUDE adverse event risk profiling
›Clinical evidence strategy based on pivotal studies

BUILD YOUR SUBMISSION

Turn strategy into a submission.

›14-section submission scaffold generated in minutes
›Cross-section consistency engine — 16 check types
›Readiness scoring with blocking issue detection
›Evidence linked to FDA sources

Built on FDA source data and established regulatory frameworks

🏛

openFDA

open.fda.gov

Device classification & MAUDE

📋

FDA accessdata

accessdata.fda.gov

510(k) clearance records

🔬

ClinicalTrials.gov

clinicaltrials.gov

Clinical evidence data

📚

PubMed / NCBI

pubmed.ncbi.nlm.nih.gov

Peer-reviewed literature

IEC 62304IEC 62366FDA AI/ML Action PlanFDA Cybersecurity Guidance 2023IMDRF SaMD Framework

Why PROTOCOL

What consultants take months to produce.
PROTOCOL drafts it in minutes.

Capability

Traditional Consulting

PROTOCOL

Regulatory strategy

6–8 week engagement

Minutes

Predicate analysis

Manual FDA database search

Automated + scored

FDA question analysis

Consultant experience only

Derived from clearance history

Submission package

8–12 weeks to draft

Drafted in minutes

Consistency review

Manual QC pass

Automated 16-point engine

Time to first draft

3 months

Under 5 minutes

What used to cost $50,000 and 3 months now takes five minutes.

Who it's for

Built for founders, RA teams, and investors who need regulatory clarity fast.

AI Medical Device Founders

Know your regulatory path before your Series A. Know your product code, predicate, and timeline on day one.

Digital Health Startups

SaMD classification and predicate strategy — without waiting months for a consultant engagement.

VC-backed MedTech

De-risk your portfolio company's regulatory strategy. PROTOCOL surfaces the questions FDA will ask before they ask them.

Regulatory Affairs Teams

Automate predicate research and regulatory intelligence. Spend expertise on strategy, not manual FDA database searches.

Platform Vision

The regulatory operating system
for medical AI.

Today

Regulatory Intelligence

›Device classification
›Predicate analysis
›FDA reviewer questions
›Submission scaffold

● Available now at fdaprotocol.com

On the Roadmap

›IFU optimization
›Pre-Sub preparation
›De Novo strategy
›EU MDR pathway

Vision

Regulatory OS

›eSTAR auto-generation
›PCCP for AI/ML
›QMS integration
›Post-market surveillance

Live at fdaprotocol.com

Bring your device description.
We'll map the path together.

30 minutes. Your device description.
Live classification, predicate analysis, and regulatory strategy.