ClearPath 510
FDA 510(k) Predicate Chain Intelligence

Map predicate device chains
with AI-powered intelligence

Enter a K-number and ClearPath downloads FDA summary PDFs, extracts predicates using AI, and maps the full chain — up to 3 levels deep.

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Visual Predicate Mapping

Interactive graph with shared ancestor detection and hierarchical layout.

AI-Powered PDF Extraction

Claude AI reads FDA summaries and extracts predicate references automatically.

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Predicate Chain Graph

0

K252685

Digital Blood Pressure Monitor

same intended use

1

K230566

Auto Digital BP Monitor

1

K232621

Blood Pressure Monitor

K202891

Transtek

K212115

Shared

K222979

Microlife

K183469

K161884

PDF missing

Root
Predicate
Shared
Missing

AI Regulatory Co-Pilot

K212115 — Arm-type Auto Digital BP

Tell me about this device and why it's a shared ancestor

ClearPath 510 AI

K212115 is an arm-type blood pressure monitor cleared Jan 2022. It's a shared ancestor because both K230566 and K232621 cite it as a predicate — indicating regulatory convergence.

What are the risks?

Primary risk is age (4+ years). However, BP monitor tech is stable — this is low-to-moderate risk.

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