510(k) Report

Devices descending from K202888

4 later devices reach Confirm Rx Insertable Cardiac Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)20213—
+2K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical20232—
+3K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott20251—
+4K253516Assert-IQ (DM5100)Abbott Medical20250—