510(k) Report

Devices descending from K192593

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical)20206—
+2K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)20200—
+2K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)20204—
+3K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)20213—
+4K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical20232—
+5K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott20251—
+6K253516Assert-IQ (DM5100)Abbott Medical20250—