Trying to enact a policy that a limits the number/age of predicates in a 501(k) application is impossible if you have no way to find them!
Im not sure why you would think that. The answer would take 5 minutes to answer with the PDFs (which is where the parent post got the info).
Additionally, not having the data in a structured format prevents seeing overall trends in the data.
The FDA already has information on product codes. here is the one for this device [1]. What is the useful trend and data one gets from grouping an iPhone app with a physical test strip for measuring glucose.
I think there is a lot of confusion in the general public about the 510k process is and what substantial equivalence means. Product drift is an intentional feature of the process, not a bug. 510k filing is not intended to be a single point control for safety and efficacy, but is implemented in context of other controls like medical device reporting and quality management.
Devices are primarily regulated at the device level, sometimes at the group level, but never at the lineage level. Im not sure what it would mean to trend and regulate as a lineage. Would that mean recalling a safe and effective product because of bad ancestor?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tp...