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Predicate Chain Graph
K252685
Digital Blood Pressure Monitor
same intended use
K230566
Auto Digital BP Monitor
K232621
Blood Pressure Monitor
K202891
Transtek
K212115
Shared
K222979
Microlife
K183469
K161884
PDF 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.