Predicate Chain

A lineage of 510(k) clearances where each device cited an earlier predicate device as its benchmark.

Predicate chains occur when a device cleared via a 510(k) subsequently serves as the Predicate device for newer submissions. Over decades, these lineages can connect modern technologies back through multiple clearance generations to legacy products.

Explore the data behind the terms

HaRi brings the FDA, MHRA, EUDAMED, Health Canada and TGA registers into one search: devices, manufacturers, product codes and safety events, all cross-referenced and free to explore.