510(k) Report

Devices descending from K251221

1 later device reach Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253516Assert-IQ (DM5100)Abbott Medical20250—