Atlas FDA

MXC

23 FDA 510(k) clearances · Product code

65 daysmedian time to decision
214 days90th percentile
23clearances measured

FDA profile

Official device name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 832 · 2022: 628 · 2023: 828 · 2024: 975 · 2025: 1,123 · 2026: 832
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Assert-IQ™ Insertable Cardiac Monitor (K230286)ABBOTT MEDICAL2023-05-17
Jot Dx Insertable Cardiac Monitor (K212206)Abbott (St. Jude Medical)2021-08-13
Confirm Rx Insertable Cardiac Monitor (K202876)Abbott (St. Jude Medical)2020-12-01
Confirm Rx Insertable Cardiac Monitor (K202888)Abbott (St. Jude Medical)2020-11-23
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (K193310)Abbott (St. Jude Medical)2020-03-17
Confirm Rx Insertable Cardiac Monitor (K192593)Abbott2019-10-18
Confirm Rx Insertable Cardiac Monitor (K190295)Abbott (St. Jude Medical)2019-04-10
Confirm Rx Insertable Cardiac Monitor (K182981)Abbott2019-03-29
myMerlin(TM) Mobile Application Model APP1001 (K173232)St Jude Medical2017-11-02
Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407)St. Jude Medical, Inc.2017-09-29
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481)St. Jude Medical, Inc.2014-05-28
SJM CONFIRM (K122161)St Jude Medical2012-11-28
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090)St. Jude Medical, Cardiac Rhythm Management Divisi2012-11-15
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A (K101968)St Jude Medical2010-09-15
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL (K091206)Transoma Medical2009-05-18
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT (K083828)Transoma2009-02-11
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR (K081365)St Jude Medical2008-08-15
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 (K073147)Transoma Medical2007-12-03
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM (K063035)Transnoma Medical, Inc.2007-10-01
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR (K011098)Medtronic Vascular2001-05-04
REVEAL PLUS INSERTABLE LOOP RECORDER (K003667)Medtronic Vascular2001-02-14
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR (K994331)Medtronic Vascular2000-01-21
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM (K972242)Medtronic Vascular1998-01-16

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Every clearance here is in the API, with alerts when new ones post.