Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MXC — Predicate Candidate Screening

23 FDA 510(k) clearances under this product code; the 50 most recent screened below.

65 daysmedian FDA review time
214 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230286Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICAL2023-05-171040
K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)2021-08-13290
K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2020-12-01640
K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2020-11-23560
K193310myMerlin Mobile Application (Android), myMerlin Mobile AppliAbbott (St. Jude Medical)2020-03-171090
K192593Confirm Rx Insertable Cardiac MonitorAbbott2019-10-18280
K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)2019-04-10580
K182981Confirm Rx Insertable Cardiac MonitorAbbott2019-03-291510
K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical2017-11-02290
K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.2017-09-292981
K133481SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)St. Jude Medical, Inc.2014-05-281960
K122161SJM CONFIRMSt Jude Medical2012-11-281310
K122090SJM CONFIRM IMPLANTABLE CARDIAC MONITORSt. Jude Medical, Cardiac Rhythm Management Divisi2012-11-151220
K101968SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100St Jude Medical2010-09-15650
K091206SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTransoma Medical2009-05-18240
K083828SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CTransoma2009-02-11500
K081365SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODSt Jude Medical2008-08-15921
K073147SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000Transoma Medical2007-12-03250
K063035SLEUTH IMPLANTABLE ECG MONITORING SYSTEMTransnoma Medical, Inc.2007-10-013670
K011098REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLAMedtronic Vascular2001-05-04230
K003667REVEAL PLUS INSERTABLE LOOP RECORDERMedtronic Vascular2001-02-14780
K994331REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLMedtronic Vascular2000-01-21290
K972242REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEMMedtronic Vascular1998-01-162140

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda