How to Find a Predicate Device: 2025 FDA Guide
- Beng Ee Lim
- 4 days ago
- 9 min read
Finding the right predicate device determines everything about your 510(k) submission. Choose wrong, and you'll face rejection, delays, and potentially hundreds of thousands in wasted development costs.
Quick Answer: A predicate device is a legally marketed U.S. device with the same intended use and technological characteristics that do not raise different questions of safety and effectiveness compared with your device. Find candidates in FDA’s Product Classification Database (by product code), FDA’s 510(k) database (by device name/manufacturer), and AccessGUDID (public UDI)—which often lists premarket submission numbers you can pivot on. Pick well and you streamline review; pick poorly and you risk NSE and costly rework.
This guide provides the step-by-step process for finding strong predicate devices that support successful 510(k) submissions.
What Is a Predicate Device?
A predicate device is a legally marketed U.S. device used as your comparison benchmark to demonstrate substantial equivalence in a 510(k). Predicates can be 510(k)-cleared, preamendments devices, reclassified devices, or De Novo–granted devices; they cannot be in violation of the FD&C Act.
Your predicate device must meet two critical requirements:
Same intended use as your device
Similar technological characteristics or differences that don't raise new safety/effectiveness questions
You must identify the predicate(s) you rely on. If you use more than one predicate, FDA recommends designating a primary predicate that is most similar in indications for use and technology to streamline review.
Types of Valid Predicate Devices
Recently Cleared 510(k) Devices (Recommended)
Most common choice for predicates
Recent clearances show current FDA expectations
Clear regulatory pathway and documentation available
Pre-Amendment Devices (Before May 28, 1976)
Grandfathered devices from before FDA oversight
May require additional documentation to prove preamendment status
Since medical science has advanced greatly since 1976, it is recommended that you use a recently cleared device under 510(k) as your predicate device
Downclassified Devices
Originally Class III devices reclassified to Class II or I
Less common but valid predicate options
De Novo Granted Devices
Devices cleared through the De Novo pathway
Valid predicates for similar novel devices
Why Predicate Selection Is Critical
A weak predicate invites RTA holds or NSE, which means more testing, possible pathway shifts, and time.
The High Cost of Wrong Predicates
Regulatory Rejection
FDA refuses to file (RTA) or issues Not Substantially Equivalent (NSE) determination
Forces costly resubmission or pathway change to De Novo/PMA
Timeline Delays
Wrong predicate adds 6-18 months to approval timeline
Late-stage predicate changes require extensive documentation updates
Development Cost Escalation
Additional testing to address differences from weak predicate
Potential clinical data requirements for technological differences
Strategic Advantages of Strong Predicates
Streamlined Approval Process
Clear substantial equivalence pathway
Reduced additional testing requirements
Faster review and clearance timelines
Reduced Development Costs
Lower testing burden when predicate closely matches your device
Clear precedent for FDA expectations and requirements
Competitive Market Intelligence
Understanding competitor positioning and claims
Insights into successful regulatory strategies in your space
Step-by-Step Predicate Search Process
Step 1: Determine Your Device Classification
Before searching for predicates, identify your device's FDA classification and product code.
Use the Product Classification Database
Go to FDA's Product Classification Database
Search by device name, regulation number, or browse by panel
Identify your 3-letter product code
Note your device class (I, II, or III) and applicable regulations
Why This Matters The classification of the device and product code is essential in searching for predicate devices. Your product code groups similar devices and provides the most targeted search results.
Step 2: Search the FDA 510(k) Database
Primary Search Methods
Product Code Search (Most Effective)
Enter your 3-letter product code in the 510(k) database
510(k)s for similar device types are usually linked in the 510(k) database by the same product code
Review all devices in your product code category
Device Name Search
Use one descriptive keyword (not full device name)
It is usually best to complete only one box in the online search form per search. The search engine searches for an exact match of text
Try variations: "ultrasound," "ultrasonic," "transducer"
Manufacturer Search
Search by known competitor names
Hyphens or spaces in names can make a difference, so try different combinations of the manufacturer's name
Step 3: Use Alternative Search Resources
Global Unique Device Identification Database (GUDID) GUDID offers expanded search capabilities beyond the 510(k) database:
Search devices currently in commercial distribution
Filter by over-the-counter vs. prescription status
GUDID is comprised of raw data entered by manufacturers without any FDA review, so verify findings in 510(k) database
Advanced Search Techniques
Search by therapeutic panel (orthopedic, cardiovascular, etc.)
Review similar devices from different product codes
Use FDA's recall database to identify devices to avoid as predicates
Step 4: Evaluate Potential Predicates
Critical Evaluation Criteria
Intended Use Alignment
Compare indications for use statements word-by-word
Ensure target patient populations match
Verify clinical applications are identical
Technological Characteristics Review these key areas for similarity:
Design and materials
Energy source and delivery method
Performance specifications
Software and algorithms (if applicable)
Sterilization and packaging
Regulatory History
Recent clearance date (within 5 years preferred)
No outstanding recalls or warning letters
Clear substantial equivalence determination
Adequate supporting documentation available
Step 5: Access and Analyze Predicate Documentation
510(k) Summary Documents
Download the PDF summary from the 510(k) database
Review indications for use, device description, and substantial equivalence comparison
Note testing methods and performance data provided
Predicate Research Checklist
□ Device has same intended use as your device
□ Technological differences don't raise new safety questions
□ Recent clearance with clear documentation
□ No regulatory issues or recalls
□ Sufficient technical detail for comparison
□ Appropriate testing standards and methods used
p/s Complizen takes away the guesswork, more here.
Advanced Predicate Selection Strategies
Using Multiple Predicates
When to Consider Multiple Predicates
Your device combines features from different existing devices
No single predicate covers all technological characteristics
Strengthen substantial equivalence argument through multiple comparisons
Split Predicate Limitations The use of split predicates is inconsistent with the 510(k) regulatory standard. You still need one primary predicate with the closest overall match.
Reference Devices vs. Predicates
Reference Devices
Support scientific methodology or standard reference values
Provide additional context but don't establish substantial equivalence
Manufacturers may identify "reference devices" within their 510(k) to support scientific methodology
Primary Predicate Requirements
Must be most similar device for indications and technology
Forms the foundation of your substantial equivalence argument
Predicate Age Considerations
Recent Predicates (Recommended)
Reflect current FDA review standards
Incorporate latest safety and performance requirements
Clear precedent for approval pathway
Older Predicates (Use Cautiously)
May require additional justification for current standards
Technology gaps may need bridging with additional data
Regulation doesn't say how old the predicate should be. It's up to us to decide
Common Predicate Selection Mistakes
Mistake 1: Choosing Convenient Over Appropriate Predicates
The Problem Companies select predicates based on available information rather than true similarity.
The Solution Prioritize intended use and technological alignment over documentation convenience. A harder-to-research but more appropriate predicate saves money long-term.
Mistake 2: Treating “Identical” As The Standard
The Problem FDA doesn’t require clones.
The Solution Differences are allowed if they don’t raise different questions of safety/effectiveness, and you support them with data. Use the 513(i) test explicitly in your comparison.
Mistake 3: Using Problematic Predicates
Red Flags to Avoid
Devices with recalls or safety issues
Predicates with unclear regulatory status
Devices no longer manufactured (though legally permissible)
Mistake 4: Inadequate Predicate Research
The Problem Superficial predicate analysis leads to substantial equivalence failures.
The Solution You should explain why you will not consider it for your file. This will also show to the Agent that you really made a deep dive. Document your entire predicate evaluation process.
Predicate Documentation and Comparison
Building Your Substantial Equivalence Argument
Side-by-Side Comparison Tables Create detailed comparisons covering:
Indications for use
Device design and components
Materials and biocompatibility
Performance specifications
Testing standards and methods
Labeling and instructions for use
Addressing Technological Differences For any differences from your predicate:
Explain why differences don't raise new safety questions
Provide supporting test data demonstrating equivalence
Reference applicable standards and guidance documents
Documentation Best Practices
Organize Your Predicate File
510(k) summary and clearance letter
Device labeling and instructions for use
Relevant testing data and standards
Manufacturing information (if available)
Any FDA correspondence or guidance related to predicate
Track Multiple Predicate Candidates Maintain comparison spreadsheets for all potential predicates to document your selection rationale and demonstrate thorough evaluation to FDA.
Emerging Technology Solutions Next-generation regulatory platforms are beginning to integrate predicate device research with comprehensive regulatory strategy planning, automating much of the manual database searching and comparison work.
FDA Database Navigation Tips
510(k) Database Search Optimization
Search Strategy Tips
FDA databases on the web are updated on or around the 5th of every month
Use exact text matches - the search engine is literal
Start broad with single keywords, then narrow results
Try different manufacturer name variations and spacing
Database Limitations to Know
510(k) database contains original application information only
Names may not reflect current owners or distributors
Some PDFs are scanned documents with OCR text extraction issues
Not all predicate information may be publicly available
Alternative Research Methods
Industry Intelligence
Conference presentations and poster sessions
Peer-reviewed publications citing specific devices
Patent searches for competing technologies
Trade publication device reviews and comparisons
Professional Networks
Regulatory consultants with device expertise
Industry association member directories
Medical device conference attendee networks
Predicate Selection Timeline and Planning
Early Development Integration
Predicate Research During Design Phase Start predicate identification during device conceptualization, not after development completion. This is much harder to adjust a finished product to meet regulatory requirements than to design it according to those requirements from the start.
Development Decision Points
Predicate selection should inform design decisions
Technology choices should consider predicate alignment
Testing protocols should match predicate standards
Resource Planning
Internal Team Requirements
Regulatory affairs expertise for FDA database navigation
Engineering input for technological characteristic comparison
Clinical input for intended use evaluation
External Support Considerations
Regulatory consultants for complex predicate evaluations
Patent attorneys for freedom-to-operate analysis
Clinical advisors for intended use refinement
When No Suitable Predicate Exists
De Novo Pathway Considerations
If your device has no appropriate predicate, you cannot use a 510(k). By default, a new (post-amendments) device is Class III under FD&C §513(f)(1)—but you can request De Novo classification under §513(f)(2) to place it in Class I or II when general and/or special controls provide a reasonable assurance of safety and effectiveness.
De Novo Request Criteria
Novel device with no appropriate predicate
Low to moderate risk device
General and special controls provide reasonable assurance of safety and effectiveness
Strategic Decision Framework
Cost comparison: De Novo vs. PMA pathway
Timeline implications: 150 days for De Novo review
Market advantage of establishing new device category
Creating Your Own Predicate
De Novo Success Creates Predicates If your De Novo request is successful, the new device's safety and efficacy can be established using the FDA's general and special controls alone. Your cleared device then becomes a predicate for future similar devices.
Competitive Positioning
First-to-market advantage in new device category
Control narrative for substantial equivalence standards
Establish testing and performance benchmarks
International Predicate Considerations
Global Regulatory Harmonization
CE Mark Device Databases
Regional Regulatory Intelligence
Health Canada Medical Device License Database
TGA Australian Register of Therapeutic Goods
PMDA Japan medical device approval information
Cross-Regional Strategy Use international device approvals to:
Validate technological approaches
Identify global competitors and solutions
Support US predicate selection rationale
Ready to find the perfect predicate device for your 510(k) submission? Smart predicate selection is the foundation of regulatory success, but manually searching multiple databases and evaluating complex technological characteristics can consume weeks of valuable time.
Coming Soon: Automated Predicate Research
Complizen is launching an AI-powered predicate device research feature as part of our comprehensive Regulatory Strategy Builder. This tool will automatically identify, evaluate, and compare potential predicates across multiple FDA databases, dramatically reducing research time while improving selection accuracy.
Frequently Asked Questions
Can I use a device that's no longer manufactured as a predicate?
Yes, an applicant may claim SE to a device that is no longer being marketed in the U.S. However, devices still in commercial distribution make stronger predicates for FDA review.
How old can my predicate device be?
There's no regulatory limit, but recent predicates (within 5 years) are preferred. Because medical technology has changed greatly since 1976, almost all 510(k) submissions claim substantial equivalence to a postamendment device.
Can I change my predicate after submitting my 510(k)?
Major predicate changes typically require withdrawal and resubmission. Minor clarifications may be addressed through FDA questions during review.
What if my predicate device has a recall?
Avoid predicates with serious recalls or ongoing safety issues. Minor recalls that have been resolved may still be acceptable with proper justification.
How many predicates should I identify?
Identify one primary predicate that most closely matches your device. Multiple predicates can support your argument but should supplement, not replace, a strong primary predicate.
What if the FDA disagrees with my predicate selection?
FDA may request additional information or suggest alternative predicates during review. Strong initial predicate research with documented rationale helps avoid this scenario.
Can I use a predicate from a different product code?
Generally not recommended. Product codes group similar devices, and cross-code predicates raise substantial equivalence questions. Exceptional cases require extensive justification.
Should I avoid predicates from competitors?
No - competitors often have the most relevant predicates. Focus on technological similarity rather than business relationships. The best predicate is the most similar device, regardless of manufacturer.
What documentation do I need from my predicate device?
At minimum: 510(k) clearance letter, device labeling, indications for use, and substantial equivalence summary. Additional technical documentation strengthens your comparison.
How do I handle proprietary information in predicate devices?
Use publicly available information from FDA databases and device labeling. Don't attempt to obtain proprietary design details - focus on performance characteristics and intended use alignment.
