510(k) Report

Devices descending from K082475

28 later devices reach Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+1K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+2K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+2K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+2K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+3K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+3K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+3K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+3K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+3K150614Reveal LINQMedtronic, Inc.201515—
+4K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+4K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+4K160809Reveal LINQMedtronic, Inc.201612—
+4K160689Reveal LINQMedtronic, Inc.20161—
+5K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+5K162855Reveal LINQMedtronic, Inc.2017111
+5K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+6K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+6K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+7K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+7K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+7K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+8K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+8K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+8K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+9K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+9K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+10K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—