510(k) Predicate Intelligence

Find Your Strongest 510(k) Predicate in Minutes

AI-powered predicate analysis backed by 91,000+ FDA clearance packages, semantic search, and FDA Best Practices compliance scoring.

Analyze Your Device No account required. Results in under 5 minutes.
Who This Is For

Built for Health-Tech Teams Navigating FDA Clearance

Startup Founders

First 510(k) submission? Get expert-level predicate analysis without the $5,000+ consultant fee. Understand your regulatory landscape before you spend.

Regulatory Affairs

Validate your predicate selection with data-driven scoring, FDA Best Practices compliance, and ready-to-use 510(k) Summary text. Save hours of manual research.

Investors & Advisors

Evaluate regulatory feasibility in minutes. Understand pathway risk, competitive landscape, and predicate strength before committing capital.

How It Works

From Device Description to Regulatory Strategy in 4 Steps

1

Describe Your Device

Enter your device description and intended use. Optionally specify if it's an AI/ML device or a modification of your own cleared device.

2

We Search 91K+ Clearances

Hybrid search combines openFDA structured data with semantic similarity across the full 510(k) summary corpus. Cross-code discovery finds predicates keyword search misses.

3

AI Analyzes Everything

Claude evaluates candidates against FDA's 4 Best Practices, scores substantial equivalence across 8 eSTAR dimensions, and traces predicate lineage chains.

4

Get Your Report

Download an 18-page branded PDF with predicate recommendation, lineage chains, pathway decision, and ready-to-use 510(k) Summary narrative.

Why K-Space

Not Just a Database Search

Most predicate tools search by product code and sort by date. We do something fundamentally different.

FDA Best Practices Aligned

Every predicate is scored against FDA's September 2023 guidance: well-established methods, safety performance, no unmitigated issues, no design-related recalls. You get a compliance scorecard, not just a list.

Semantic Search Across 91K+ Submissions

We don't just match product codes. Our vector database embeds every 510(k) summary and finds semantically similar devices across ALL product codes — catching predicates keyword search misses entirely.

Predicate Lineage Chains

See who your predicate cited as THEIR predicate, and who they cited. Trace citation chains 3 levels deep from actual 510(k) summary text. Understand chain depth and risk before FDA asks.

AI-Powered Scoring & Analysis

Claude Sonnet evaluates candidates with 50% intended use, 35% technology similarity, 15% recency weighting — then produces an 8-dimension substantial equivalence comparison aligned with eSTAR format.

Regulatory Pathway Decision Engine

Not just "510(k)" — we evaluate Traditional, Special, Abbreviated, De Novo, Breakthrough Device, and PMA pathways with specific eligibility reasoning, PCCP assessment, and pre-submission meeting recommendations.

Ready-to-Use 510(k) Summary Text

Get a multi-paragraph predicate selection narrative formatted per FDA guidance Section VI. Explains predicate choice, best practices compliance, and substantial equivalence basis. Copy, adapt, submit.

Download Sample Report
The Report

18-Page Predicate Intelligence Report

Every report includes comprehensive regulatory intelligence ready for your team, your board, or your regulatory consultant.

✓ Executive Summary
✓ Primary Predicate Recommendation
✓ FDA Best Practices Scorecard
✓ All Ranked Candidates with FDA Links
✓ Similar Historical Devices (Semantic Search)
✓ Predicate Lineage (Citation Chains)
✓ 8-Dimension SE Comparison (eSTAR Aligned)
✓ Regulatory Pathway Decision
✓ De Novo & Breakthrough Eligibility
✓ Testing Implications
✓ Safety Summary (MAUDE + Recall Flagging)
✓ Market Context & Competitive Landscape
✓ AI/ML Device Assessment (When Applicable)
✓ Predicate Selection Narrative (510(k) Summary Ready)
✓ Action Checklist & Next Steps
Pricing

$499per report

One-time purchase. No subscription required.

  • ✓ Full 18-page intelligence report
  • ✓ FDA Best Practices compliance scoring
  • ✓ Semantic search across 91K+ clearances
  • ✓ Predicate lineage chain analysis
  • ✓ Ready-to-use 510(k) Summary narrative
  • ✓ Regulatory pathway decision with alternatives
  • ✓ Downloadable branded PDF
Analyze Your Device

Need multiple reports? Ask about consultant plans.

Regulatory References

Built on FDA Guidance

The tool's predicate selection methodology is anchored in FDA's September 2023 "Best Practices for Selecting a Predicate Device" guidance, supported by the documents listed below. Every report cites the specific guidance informing each section.

FAQ

Frequently Asked Questions

How accurate is the predicate recommendation?
Our system searches 91,000+ FDA clearance packages using semantic similarity (not just product code matching) and evaluates candidates against FDA's own Best Practices guidance. The AI ranks candidates using 50% intended use alignment, 35% technology similarity, and 15% recency. However, this is a research tool — all recommendations should be validated by a qualified regulatory professional.
What data sources do you use?
We combine three data sources: (1) openFDA REST API for real-time 510(k) clearance data, MAUDE adverse events, and recall records, (2) a vector database of 91,000+ extracted 510(k) summary texts from the boleary.com public corpus (CC BY 4.0), and (3) a predicate lineage graph built by extracting K-number citations from those summaries.
Can I use this for AI/ML medical devices?
Yes. Check the "AI/ML device" toggle in the input form and specify whether your algorithm is locked or continuously learning. The report will include IMDRF SaMD risk classification, PCCP requirement assessment, and AI/ML-specific documentation guidance based on FDA's January 2025 AI-Enabled Device Software Functions guidance.
How is this different from searching openFDA myself?
openFDA search by product code returns results sorted by date — the newest devices, not the most relevant. Our semantic search finds the best-matching predicates based on actual device descriptions, regardless of product code. We also add safety analysis, recall classification, lineage chains, and FDA Best Practices scoring that openFDA doesn't provide.
Is the report suitable for my 510(k) submission?
The report includes a Predicate Selection Narrative formatted per FDA guidance Section VI that can serve as a starting point for your 510(k) Summary. However, this is an AI-generated research tool — all content should be reviewed and adapted by a qualified regulatory professional before submission.
Do you offer consultant or multi-report plans?
Not yet, but we're building consultant subscription plans ($599-1,499/month) with white-label exports and portfolio analysis. Contact info@keenr.ai to discuss early access.
How often is the database updated?
The vector database is updated monthly via an automated pipeline that downloads the latest boleary.com corpus, identifies new submissions, generates embeddings, and uploads to our search index. The openFDA data is queried in real-time.

Ready to Find Your Predicate?

Get your 510(k) Predicate Intelligence Report in minutes.

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This tool is for informational and research purposes only and does not constitute regulatory, legal, or professional advice. All analysis is AI-generated and should be reviewed by a qualified regulatory professional. Data sourced from openFDA and publicly available 510(k) clearance packages. Terms · Privacy · FDA.gov