510(K) PREDICATE INTELLIGENCE · PRIVATE BETA

Find your strongest 510(k) predicate in minutes.

AI-powered predicate analysis backed by 91K+ indexed 510(k) summaries, the full openFDA clearance history, FDA guidance documents, and semantic search. FDA Best Practices compliance scoring on every candidate.

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KEENR · 510(K) PREDICATE REPORT

DEVICE · K-XXXXXX

Predicate Intelligence Report

Generated for review · 25+ pages

PART 1

Executive Summary

Recommended predicate
Pathway decision

PART 2

Selection Strategy

91K+ semantic search
Lineage 3 levels deep

PART 3

Technical Evidence

8-dimension SE matrix
Best Practices scorecard

PART 4

Submission Framework

Pathway + PCCP + eSTAR
Action checklist

Citation-linked · auditable PDF + Word

WHO THIS IS FOR

Built for health-tech teams navigating FDA clearance.

PERSONA · 01

Startup founders

First 510(k) submission? Get expert-level predicate analysis in minutes, without a multi-week, $5,000+ engagement. Understand your regulatory landscape before you spend.

PERSONA · 02

Regulatory affairs

Validate predicate selection with data-driven scoring, FDA Best Practices compliance, and ready-to-use 510(k) Summary text, whether you're doing the work in-house or working with an outside consultant. Save hours of manual research either way.

PERSONA · 03

Consultants & advisors

Deliver predicate analysis to your clients faster. Use Keenr as your research engine while you focus on strategy and client relationships. White-label exports and multi-report plans coming soon.

PERSONA · 04

Investors & advisors

Evaluate regulatory feasibility in minutes. Understand pathway risk, predicate strength, and competitive landscape before committing capital. Same report your portfolio companies will use, ready to share.

HOW IT WORKS

From device description to regulatory strategy in 4 steps.

STEP 01

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.

STEP 02

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.

STEP 03

AI evaluates each candidate

Our reasoning loop scores every candidate against FDA's 4 Best Practices criteria, runs an 8-dimension substantial equivalence comparison aligned with eSTAR, and traces predicate lineage chains up to 3 levels deep.

STEP 04

Get your report

Download a 25+ page branded PDF with predicate recommendation, lineage chains, pathway decision, and ready-to-use 510(k) Summary narrative. AI/ML reports run longer with PCCP, foundation model, and algorithm change sections.

WHY KEENR

Not just a database search.

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

METHODOLOGY

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.

RETRIEVAL

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.

EVIDENCE

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/ML DEPTH

AI/ML device depth, built in

Every report includes IMDRF SaMD risk classification, Predetermined Change Control Plan (PCCP) requirement assessment, and AI/ML-specific documentation guidance based on FDA's January 2025 AI-Enabled Device Software Functions guidance. Foundation-model disclosure tracking and algorithm-change precedent libraries are in development. No competitor in the AI-native regulatory space ships this depth today.

PATHWAY ENGINE

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.

OUTPUT

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.

EARLY-STAGE STRATEGY · RESEARCH OUTPUTS

What this report does for your submission.

Twelve research outputs across the five areas of a 510(k): early-stage strategy your team, your consultant, or your institutional partner can build a submission around.

REGULATORY PATHWAY STRATEGY

Accelerates Pathway Planning

Recommends a regulatory pathway with the reasoning behind it, comparing Traditional 510(k) against Abbreviated, De Novo, and Breakthrough Device for your device profile. Gives your team or consultant a defensible starting point.

Tests Product Classification

Tests whether the product code you're considering fits your device's technical features, and surfaces adjacent codes worth a closer look. Reduces the risk of building a submission on a misclassified code.

PREDICATE & MARKET INTELLIGENCE

Strengthens Predicate Selection

Ranks predicate candidates on a 100-point scale using FDA's September 2023 Best Practices criteria. Produces a scored shortlist of the most defensible substantial-equivalence options, with the full scorecard visible for every candidate, ready for a regulatory consultant's review.

Strengthens Safety Vetting

Cross-checks every candidate against openFDA: MAUDE adverse-event counts (voluntary + mandatory) and design-related recall flags. Surfaces safety patterns worth investigating before your team or consultant builds the substantial-equivalence argument.

Uncovers Competitive Insights

Quantifies the clearance landscape for your product code (volume, average review time, recent activity), and tracks semantically adjacent codes for competitive devices a keyword search might miss.

SUBMISSION DOCUMENTATION & TEMPLATES

Reduces Drafting Time

Produces a draft Predicate Selection Narrative aligned with FDA Section VI requirements. A working draft your team or consultant can adapt, not a finished submission.

Maps to eSTAR Template

Routes the device analysis to mandatory eSTAR sections: Section 4 (Device Description), Section 5 (Substantial Equivalence), Section 9 (Software Documentation), Section 12 (Performance Testing). Cuts the translation work between research and template inputs.

TESTING, COMPLIANCE & ROADMAPPING

Clarifies Compliance Needs

Assesses whether your system likely requires the "Enhanced" software documentation level under FDA's guidance, and outlines the design specs, traceability matrices, and cybersecurity protocols reviewers typically expect.

Informs Engineering Investment

Produces a prioritized launch checklist: Pre-Submission meeting timing, multi-site validation with demographic stratification, human factors testing. Helps focus engineering and clinical investment on the work most likely to matter at FDA review.

Consolidates Regulatory Research

Compiles the FDA guidance documents most relevant to your device, each with a direct link and a one-sentence breakdown of how the framework applies.

AI/ML ALGORITHM LIFECYCLE MANAGEMENT Included when your device is AI/ML

Informs PCCP Strategy

Drafts a Predetermined Change Control Plan (PCCP) outline your team or consultant can develop with FDA. Reduces the risk of the cycle where every post-market algorithm update triggers a new submission.

Anticipates AI/ML Review Risks

Surfaces recurring AI/ML failure patterns from cleared devices, with suggested mitigation areas for acceptance criteria and demographic dataset tracking. Anticipates the issues that most often trigger FDA additional-information requests.

PRICING · TRANSPARENT

Pay per report. Or by the bundle.

$499 per single report, with 3-pack and 10-pack bundles for teams running multiple devices. Partner subscriptions add editable Word export and portfolio dashboards.

See full pricing Start an analysis

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.

What is a 510(k) predicate device?

A 510(k) predicate device is a legally marketed device cited in a 510(k) submission to establish substantial equivalence. FDA requires that the predicate have the same intended use and similar technological characteristics, or different technology that does not raise different questions of safety and effectiveness. Predicate selection drives the entire submission: what testing FDA will expect, how performance is benchmarked, and how the device is positioned in the regulatory record. FDA's September 2023 “Best Practices for Selecting a Predicate Device” guidance defines the selection criteria — well-established methods, similar safety performance, no unmitigated use problems, no design-related recalls — that Keenr scores every candidate against.

How accurate is the predicate recommendation?

Our system searches 91K+ indexed 510(k) summaries plus the full openFDA clearance history using semantic similarity (not just product code matching) and evaluates candidates against FDA's own Best Practices guidance. Candidates are scored on intended-use alignment, technology similarity, and clearance recency, with weights tuned to FDA's 2023 Best Practices guidance — and the full scorecard is shown for every candidate in the report. 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.

What does a Keenr report cost, and are there volume discounts?

A single Keenr Predicate Intelligence Report is $499 during private beta ($999 at general availability). For teams running multiple devices, we offer a 3-report bundle at $1,299 ($433 per report, saves $198 vs. singles) and a 10-report bundle at $3,999 ($399 per report, saves $991 vs. singles). Bundle credits never expire. AI/ML-specific deliverables (PCCP Intelligence, foundation model disclosure assessment, algorithm change precedents) are included on every report at no additional cost. See the pricing page for full details, or email info@keenr.ai about consultant or team plans.

Do you offer consultant or multi-report plans?

Yes. Consultant white-label and team subscriptions are in development for launch later this year. Email info@keenr.ai for early access.

How often is the database updated?

The vector database is refreshed regularly with the latest 510(k) summaries; openFDA data is queried in real time.

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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