Expert work at software speed.
Keenr builds AI agents for medtech regulatory and commercial research. Starting with 510(k) predicate research — the kind of narrow, intelligence-heavy work that used to take weeks and a $5,000–$15,000 engagement.
- PRIVATE BETA
- 510(k) Predicate Finder, live now
- AI/ML DEPTH
- First-of-its-kind PredeterminedChange Control Plan (PCCP) libraryfor AI/ML medical devices
- FOR REGULATORY TEAMS
- And the consultantswho 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
For every dollar spent on regulatory software, six are spent on regulatory services. We're rebuilding that work as software, one specialized agent at a time.
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 25+ 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 25+ page report generated with citations30 sec
- 06 Re-analyze anytime, re-audit, re-shareon demand
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, regulatory pathway decision, and a one-page version a non-RA reader can act on.
Selection Strategy & Market Landscape
Product Code Regulatory Trends (clearance volume, average review time, key manufacturers), AI/ML Device Assessment, Cross-Code Landscape, all ranked candidates with full scorecards, and predicate citation lineage three levels deep.
Technical Evidence & Substantial Equivalence
8-dimension SE comparison aligned to eSTAR. FDA Best Practices Scorecard with PASS / PARTIAL / CONCERN status. Safety summary across MAUDE adverse events and recall classifications.
Submission Framework & Action Plan
Pathway decision (Traditional / Special / Abbreviated 510(k), De Novo, Breakthrough, PMA). Applicable FDA guidance citations. PCCP Intelligence (AI/ML tier). eSTAR Optimization recommendations. Testing implications. 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 today. A platform of specialized agents tomorrow.
Predicate Finder is the first agent. The next ones are already in development, each compressing a discrete piece of research work into a single session.
Pre-Submission Strategist
Q-Sub meeting prep, pathway analysis, FDA precedent search.
Compresses a $10K–$25K engagement.
Cybersecurity Package Generator
FDA 2023 cyber guidance package, SBOM, threat model templates.
Compresses a $20K–$50K engagement.
Reimbursement Pathway Analyzer
CPT/HCPCS/NTAP crosswalks. Coverage and coding strategy from clearance forward.
Compresses a $25K–$75K engagement.
Ready to see what your predicate landscape actually looks like?
No account required for the first search. $499 per report.