FDA 510(k) Classification
Matching & Analysis
Instantly identify your medical device's FDA regulatory class, product code, and applicable regulations. Our AI-powered classification engine analyzes your device description against the complete FDA database to provide accurate classification matching in minutes—not weeks of manual research.
Get instant classification results. No credit card required.
What is FDA Device Classification?
FDA device classification determines your regulatory pathway, testing requirements, and submission strategy. Accurate classification is the foundation of a successful 510(k) submission.
Class I Devices
Low-risk devices exempt from premarket notification (510(k)). Most are subject to general controls only. Examples: tongue depressors, bandages, surgical instruments.
Class II Devices
Moderate-risk devices requiring 510(k) clearance. Must demonstrate substantial equivalence to a predicate device. Most medical devices fall into this category.
Class III Devices
High-risk devices requiring PMA (Premarket Approval) or De Novo classification. Life-sustaining or life-supporting devices, or those with insufficient predicate history.
How AI Classification Works
Our advanced classification engine combines AI reasoning with comprehensive FDA regulation databases to provide accurate, evidence-based classification results.
Device Description Analysis
AI extracts and structures key device characteristics: intended use, indications for use, design principles, materials, energy sources, and technological characteristics.
Regulation Discovery
Tri-channel search across FDA regulations (21 CFR), product code database, and guidance documents. AI generates targeted queries and retrieves relevant regulatory contexts.
Semantic Matching
Advanced AI analyzes semantic compatibility between your device and candidate regulations. Hard gates filter incompatible regulations before scoring.
Product Code Enumeration
System retrieves all potential product codes linked to matching regulations. Each product code represents a specific device type within a regulation.
Deep Scoring & Validation
Multi-dimensional scoring evaluates alignment across intended use, technological characteristics, risk profile, and precedent history. Confidence scores and evidence citations provided.
Confidence Assessment
Final output includes confidence levels (95%+ proceed, 90-95% human review recommended, <90% Q-Sub recommended). Clear rationale and evidence trail for every result.
Why Use AI-Powered Classification?
Traditional classification research takes weeks and requires deep regulatory expertise. AI classification delivers results in minutes with comprehensive evidence.
Minutes, Not Weeks
Get classification results in 5-15 minutes instead of spending weeks manually searching FDA databases and regulations.
AI-Powered Accuracy
95%+ accuracy rate through multi-source validation, semantic analysis, and confidence scoring. Every result includes evidence citations.
Comprehensive Evidence
Every classification includes cited FDA regulations (21 CFR), product codes, guidance documents, and precedent examples for your review.
Risk Identification
Identifies potential classification ambiguities, multiple plausible classifications, and recommendations for Q-Submission when confidence is low.
Regulatory Pathway
Classification determines your submission pathway: Traditional 510(k), Special 510(k), Abbreviated 510(k), or recommendations for De Novo/PMA.
Cross-Validated Results
Results are cross-validated against FDA precedent database, ensuring alignment with FDA's historical classification decisions.
Complete Classification Analysis
Get comprehensive classification results with all the information you need to move forward with confidence.
Product Code Identification
Identifies the specific FDA product code(s) that match your device. Product codes determine specific controls, testing requirements, and predicate search strategies.
21 CFR Regulation Matching
Matches your device to the appropriate FDA regulation (21 CFR Part 862-892). Provides regulation text, classification criteria, and regulatory history.
Special Controls Identification
Identifies applicable special controls (standards, testing requirements, labeling) required for your device classification.
Regulatory Pathway Recommendation
Recommends the appropriate submission pathway based on classification: Traditional, Special, or Abbreviated 510(k), or De Novo/PMA guidance.
Confidence Scoring
Provides confidence scores (0-100%) with clear thresholds: 95%+ proceed, 90-95% human review, <90% Q-Sub recommended for FDA pre-submission meeting.
Precedent Analysis
Shows similar devices previously classified by FDA, including their K-numbers, product codes, and classification rationale for reference.
Frequently Asked Questions
Common questions about FDA device classification and our AI-powered classification tool.
How accurate is AI-powered FDA device classification?
Cruxi's AI classification system achieves 95%+ accuracy by combining multiple data sources, FDA regulations database, and precedent analysis. The system cross-validates results and provides confidence scores for each classification match. For novel devices or low-confidence results, the system recommends FDA Pre-Submission (Q-Sub) meetings.
Can I use AI classification results for FDA submissions?
Yes. Cruxi's classification results are based on official FDA regulations (21 CFR), product code database, and historical precedent. All results include evidence citations. However, final classification should always be confirmed with your regulatory affairs team or FDA Pre-Submission (Q-Sub) for novel devices or when confidence scores are below 95%.
What information do I need to provide for classification?
You need to provide: (1) Intended Use - what the device is used for and its medical purpose, (2) Indications for Use - specific patient population and medical conditions, (3) Device Description - materials, design, dimensions, and physical characteristics, (4) Technology characteristics - energy sources, mechanism of action, principles of operation, and any software components.
What if my device matches multiple product codes?
The system will identify all plausible product codes with confidence scores. You should review each match and select the primary product code that best represents your device. In some cases, multiple product codes may be relevant if your device combines features from different device types. The system provides guidance on selecting the most appropriate classification.
What does a low confidence score mean?
A confidence score below 90% typically indicates: (1) Novel device with no clear precedent, (2) Multiple plausible classifications that require human judgment, (3) Ambiguous device characteristics that need clarification. In these cases, the system recommends FDA Pre-Submission (Q-Sub) to get FDA's official classification guidance before proceeding with 510(k) development.
How long does classification analysis take?
AI-powered classification typically completes in 5-15 minutes. The system analyzes your device description, searches comprehensive FDA databases, performs semantic matching, and generates detailed results with evidence citations. Traditional manual classification research can take weeks of regulatory affairs expert time.