Expert work at software speed.
Keenr turns the $5,000–$15,000, multi-week 510(k) predicate search into a $499 report delivered in one session. AI agents for medtech regulatory and commercial research.
- LIVE NOW
- 510(k) Predicate Finder
- AI/ML DEPTH
- 80+ cleared-PCCP library + foundation-model tracker for AI/ML medical devices
- FOR REGULATORY TEAMS
- And the consultants who work with them
91K+ SUMMARIES · OPENFDA · FDA GUIDANCE
> cardiac ct analysis, image post-processing▍
AI/ML device · PCCP detected
CT cardiac analysis software, class II
- Intended use match
- Technology match
- Performance partial
Finding predicates for a 510(k) is narrow, laborious, expensive. Exactly the shape of work AI agents handle well.
The same research, two ways. Below: the manual research portion of a 510(k) workflow, mapped step-for-step against what our agent does in a single session. The output is a 35+ page intelligence report with citations, evidence, and a drafted 510(k) Summary you can adapt and submit.
Weeks of work. A static deliverable.
A regulatory team or consultant pulls predicates by hand, builds the comparison table, drafts the memo, and delivers it. The analysis is locked in a one-time deliverable instead of a tool the team can re-run as the device evolves.
- 01 Kickoff call & scoping memo2-4 days
- 02 Manual FDA database search3-5 days
- 03 Individual summary review3-7 days
- 04 SE comparison drafting2-4 days
- 05 Deliverable write-up & final memo2-3 days
- 06 Re-running the analysis means re-running the workevery time
A specialized agent. Evidence you can audit.
Predicate Finder reads every 510(k) summary, reasons over substantial equivalence, and returns a drafted analysis with citations. Inspect the reasoning, not just the answer, and re-run anytime the device evolves.
- 01 Describe device & intended use90 sec
- 02 Agent scans 91K+ summaries + openFDA75 sec
- 03 Safety check (MAUDE + recalls)45 sec
- 04 AI analyzes across 8 SE dimensions90 sec
- 05 35+ page report generated with citations30 sec
- 06 Re-analyze anytime, re-audit, re-shareon demand
For every dollar spent on regulatory software, six are spent on regulatory services. We're turning that services spend into software.
- 91K+
- indexed 510(k) summaries
- 80+
- cleared PCCPs in the library
- 8
- SE dimensions compared
- ×3
- predicate lineage depth
- 2 wks
- corpus refresh cadence
Keenr automates the manual research portion of any 510(k) workflow, whether you're a regulatory team, a founder, or a consulting firm. The judgment layer is still yours.
Every section a regulatory reviewer expects. None of the manual labor.
A complete predicate intelligence report, organized into four narrative parts. Every claim is citation-linked to its source. Every score is shown in full, with the formula visible.
Executive Summary
- Recommended predicate + primary risks
- Readiness grade + FDA decision-time benchmark
- Regulatory pathway decision
- One-page summary for non-RA readers
Selection Strategy & Market Landscape
- Product-code trends: volume, review times
- Product Code Review + high-fit alternates
- All ranked candidates, full scorecards
- Citation lineage, three levels deep
Technical Evidence & Substantial Equivalence
- 8-dimension SE comparison, eSTAR-aligned
- Best Practices: PASS / PARTIAL / CONCERN
- Code-level MAUDE safety signal
- Per-candidate safety deep dive + FDA links
Submission Framework & Action Plan
- Six-pathway decision + Pre-Sub packet
- Matched guidance · IDE · PCCP (AI/ML)
- Tests annotated with consensus standards
- Recommended next steps
Every score is auditable. The Score Composition appendix shows every weight applied to every candidate. The Predicate Selection Narrative is formatted to FDA Section VI requirements and ready to adapt as your 510(k) Summary draft.
One agent per regulatory job.
Predicate Finder is the first. Each agent compresses a discrete piece of research work into a single session.
Reimbursement Pathway Analyzer
From clearance to coverage: CPT/HCPCS and ICD-10 candidates, Medicare pricing across three fee schedules, payer coverage outlook, and an A–F reimbursement-readiness grade.
Built. Running with design partners.
Pre-Submission Strategist
Q-Sub meeting prep, pathway analysis, FDA precedent search.
Cybersecurity Package Generator
FDA 2023 cyber guidance package, SBOM, threat model templates.
Ready to see what your predicate landscape actually looks like?
No account required for the first search. $499 per report.