510(k) Report

Devices descending from K230286

2 later devices reach Assert-IQ™ Insertable Cardiac Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott20251—
+2K253516Assert-IQ (DM5100)Abbott Medical20250—