Atlas FDA

MXD

33 FDA 510(k) clearances · Product code

67 daysmedian time to decision
172 days90th percentile
33clearances measured

FDA profile

Official device name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1025
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 694 · 2022: 1,362 · 2023: 1,766 · 2024: 3,019 · 2025: 3,415 · 2026: 2,078
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIOMONITOR IV (471155) (K261074)Biotronik, Inc.2026-05-01
Assert-IQ (DM5100) (K253516)ABBOTT MEDICAL2025-12-18
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221)Abbott2025-09-17
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) (K252593)Boston Scientific Corporation2025-09-12
LINQ II™ Insertable Cardiac Monitor (ICM) (K240693)Medtronic, Inc.2024-03-28
LINQ II Insertable Cardiac Monitor (K233562)Medtronic, Inc.2023-12-06
LINQ II™ Insertable Cardiac Monitor (LNQ22) (K233320)Medtronic, Inc.2023-10-31
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
BIOMONITOR IV (K230375)Biotronik, Inc.2023-05-19
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (K230553)Medtronic, Inc.2023-04-26
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System (K223630)Medtronic, Inc.2023-04-05
LINQ II Insertable Cardiac Monitor (K221962)Medtronic, Inc.2022-08-25
BIOMONITOR IIIm, BIOMONITOR III (K221856)Biotronik, Inc.2022-07-27
Reveal LINQ Insertable Cardiac Monitor (K212008)Medtronic, Inc.2021-07-22
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System (K210484)Medtronic, Inc.2021-06-11
LINQ II Insertable Cardiac Monitor (K211304)Medtronic, Inc.2021-05-28
LUX-Dx Insertable Cardiac Monitor (K210608)Boston Scientific Corporation2021-05-25
Biomonitor III, Biomonitor IIIm (K201865)Biotronik, Inc.2020-12-08
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (K200795)Medtronic, Inc.2020-07-03
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (K193473)Boston Scientific Corporation2020-06-26
Biomonitor III, Biomonitor IIIm (K200444)Biotronik, Inc.2020-04-23
BIOMONITOR III, Remote Assistant III (K190548)Biotronik, Inc.2019-07-05
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set (K171514)Biotronik, Inc.2017-06-29
BioMonitor 2-AF, BioMonitor 2-S (K170628)Biotronik, Inc.2017-03-31
Reveal LINQ (K162855)Medtronic, Inc.2017-02-23
Reveal LINQ Insertable Cardiac Monitor (K163460)Medtronic, Inc.2017-02-14
Reveal LINQ (K160809)Medtronic, Inc.2016-05-26
Reveal LINQ (K160689)Medtronic, Inc.2016-04-22
BioMonitor 2-AF, BioMonitor 2-S (K152995)Biotronik, Inc.2016-04-11
Reveal LINQ (K150614)Medtronic, Inc.2015-08-06
BioMonitor (K143503)Biotronik, Inc.2015-03-19
BIOMONITOR (K132960)Biotronik, Inc.2014-06-06
REVEAL LINQ INSERTABLE CARDIAC MONITOR (K132649)Medtronic, Inc.2014-02-14

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