Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

May 9, 2023, Opinion: "A recent study¹ reported the association between characteristics of predicate devices and recalls of medical devices relying on substantial equivalence to the devices cleared under the 510(k) submission pathway. The analysis relied on the ability to collect information on predicate devices using an algorithm that extracts unique predicate medical device identifiers."