510(k) Submission Pricing
Transparent, credit-based pricing for FDA 510(k) submissions. Pay only for what you use, or choose a professional membership for regular users.
How the Credit System Works
Cruxi uses a credit-based pricing system that gives you flexibility and transparency. Credits are the currency you use to access our regulatory services. Here's how it works:
account_balance_wallet Purchase Credits
Buy credits in packages or individually. Credits never expire and can be used for any service.
auto_awesome Use for Services
Each service costs a specific number of credits. Credits are deducted only when services are successfully completed.
refresh Monthly Membership
Professional members receive 50 credits monthly that refresh each billing cycle. Perfect for consultants and frequent users.
security Safe & Transparent
If a service fails, you don't lose credits. Credits are only deducted after successful completion.
💡 Pro Tip: When you pay for a full submission ($1,000), you receive 10 credits added to your account. If project creation fails, you keep the credits and can try again or use them for other services.
Service Pricing
All pricing is the same for everyone—no member/non-member distinction. Here's what each service costs:
510(k) Submission Full Workflow
Complete 510(k) submission bundle with all services included:
- check_circleDevice Classification
- check_circlePredicate Analysis
- check_circleRegulatory Assessment
- check_circleEvidence & Testing Plan
- check_circleeSTAR-style Draft Content
$1,000 10 Credits
How it works: When you pay $1,000, you receive 10 credits in your account. These credits are used when you successfully create your full submission project. If project creation fails, you keep the credits.
510(k) Microservices
Individual microservices for specific regulatory tasks:
- check_circleClassification Matching
- check_circleFind Predicate
- check_circleRegulatory Assessment
- check_circleRTA Check
$200 2 Credits Each
Each microservice costs 2 credits ($200). Perfect for targeted regulatory analysis without purchasing a full submission.
Pricing Structure: Our current pricing reflects our commitment to making enterprise-level regulatory services accessible to medical device companies and regulatory professionals. These rates represent our investment in building long-term partnerships within the regulatory community. As we continue to expand our platform capabilities and service offerings, pricing will be adjusted to align with the comprehensive value we deliver.
Note: Other services (De Novo, PMA, IDE, Breakthrough, Q-Submission, EU MDR, UKCA, Health Canada, TGA Australia) are currently in beta and calibration. Access is limited to select groups of professionals.
Credit Packages
Purchase credits in packages to save money. All credits never expire and can be used for any service:
| Package | Credits | Price | Price per Credit | Savings |
|---|---|---|---|---|
| Starter | 5 credits | $500 | $100/credit | — |
| Professional | 15 credits | $1,350 | $90/credit | 10% discount |
| Agency | 40 credits | $3,200 | $80/credit | 20% discount |
| Custom | Any amount | $100/credit | $100/credit | — |
Professional Membership
Perfect for regulatory consultants, frequent users, and agencies who need regular access to our services:
Professional Membership
$500/month
What's included:
- check_circle50 credits per month (refreshes monthly)
- check_circlePriority support
- check_circleDedicated account manager
- check_circleAdvanced analytics
- check_circleUnlimited microservice access
Best for: Regulatory consultants managing multiple projects, organizations with regular submission needs, and agencies handling multiple clients.
Note: Monthly credits expire at the end of each billing cycle if unused. Purchased credit packages never expire.
Credit Usage Examples
Here are some common scenarios to help you understand how credits work:
Scenario 1: One-Time Submission
You need one full 510(k) submission. Purchase the full submission bundle for $1,000 (10 credits). Use all 10 credits when you create the project.
Scenario 2: Multiple Microservices
You need classification and predicate analysis for 5 devices. That's 10 microservices × 2 credits = 20 credits. Purchase the Agency package (40 credits for $3,200) and have credits left over for future use.
Scenario 3: Regular Consultant
You handle 2-3 submissions per month. Get Professional Membership ($500/month) for 50 credits. That's enough for 5 full submissions or 25 microservices per month.
Scenario 4: Mixed Usage
You have 10 credits from a full submission purchase. Use 2 credits for a classification microservice, leaving 8 credits for future use. Credits never expire.
Frequently Asked Questions
Do credits expire?
Purchased credits never expire. Credits from credit packages (Starter, Professional, Agency) and custom purchases can be used at any time. However, credits included with Professional Membership (50 credits/month) expire at the end of each monthly billing cycle if unused.
What happens if a service fails?
If a service fails due to technical issues on our end, credits are not deducted. Credits are only deducted when services are successfully completed. If you pay for a full submission and project creation fails, you keep the 10 credits and can try again or use them for other services.
Can I use credits for full submissions?
Yes! When you pay $1,000 for a full submission, you receive 10 credits. These credits are then used when you create your full submission project. You can also use purchased credits for full submissions if you have enough credits in your account.
Is membership worth it?
Professional Membership is ideal if you handle multiple submissions regularly (2+ per month) or need frequent access to microservices. At $500/month for 50 credits, it's cost-effective for consultants and organizations. If you only need occasional services, purchasing credit packages as needed is more flexible.
Can I mix membership credits with purchased credits?
Yes! All credits work the same way. Membership credits are used first (since they expire monthly), then purchased credits. You can always see your credit balance in your account dashboard.
Ready to Get Started?
Choose the pricing option that works best for your needs. All services use the same transparent credit system.