Product code MXD
- Device name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1025
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | 2026-05-01 |
| K253516 | Assert-IQ (DM5100) | ABBOTT MEDICAL | 2025-12-18 |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | 2025-09-17 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | 2025-09-12 |
| K240693 | LINQ II™ Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | 2024-03-28 |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2023-12-06 |
| K233320 | LINQ II™ Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | 2023-10-31 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023-08-19 |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | 2023-05-19 |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | 2023-04-26 |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | 2023-04-05 |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2022-08-25 |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022-07-27 |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021-07-22 |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | 2021-06-11 |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2021-05-28 |
| K210608 | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | 2021-05-25 |
| K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-12-08 |
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | Medtronic, Inc. | 2020-07-03 |
| K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US | Boston Scientific Corporation | 2020-06-26 |
| K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-04-23 |
| K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | 2019-07-05 |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | Biotronik, Inc. | 2017-06-29 |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2017-03-31 |
| K162855 | Reveal LINQ | Medtronic, Inc. | 2017-02-23 |
| K163460 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2017-02-14 |
| K160809 | Reveal LINQ | Medtronic, Inc. | 2016-05-26 |
| K160689 | Reveal LINQ | Medtronic, Inc. | 2016-04-22 |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2016-04-11 |
| K150614 | Reveal LINQ | Medtronic, Inc. | 2015-08-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415067055095 | Assert-IQ™ | ST. JUDE MEDICAL, INC. | 2026-01-05 |
| 05415067053275 | Merlin.net™ | ST. JUDE MEDICAL, INC. | 2025-10-21 |
| 00802526618208 | myLUX™ Patient App | BOSTON SCIENTIFIC CORPORATION | 2025-04-11 |
| 00802526618215 | myLUX™ Patient App | BOSTON SCIENTIFIC CORPORATION | 2025-04-11 |
| 00802526625404 | LUX-Dx™ | BOSTON SCIENTIFIC CORPORATION | 2024-09-30 |
| 00763000754914 | CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) Application | MEDTRONIC, INC. | 2024-04-25 |
| 00763000891091 | CareLink SmartSync™ LINQ II™ Platform Application | MEDTRONIC, INC. | 2024-04-25 |
| 00802526621017 | LUX-Dx™ Clinic Assistant Mobile Device | BOSTON SCIENTIFIC CORPORATION | 2023-12-14 |
| 00763000613747 | LINQ II™ | MEDTRONIC, INC. | 2023-11-19 |
| 00802526621000 | myLUX™ Mobile Device | BOSTON SCIENTIFIC CORPORATION | 2023-09-08 |
| 00802526623103 | myLUX™ Patient App | BOSTON SCIENTIFIC CORPORATION | 2023-08-31 |
| 00802526621307 | myLUX™ | BOSTON SCIENTIFIC CORPORATION | 2023-08-31 |
| 00802526620713 | LUX-Dx II™ | BOSTON SCIENTIFIC CORPORATION | 2023-08-31 |
| 00802526620706 | LUX-Dx II+™ | BOSTON SCIENTIFIC CORPORATION | 2023-08-31 |
| 00802526623110 | myLUX™ Patient App | BOSTON SCIENTIFIC CORPORATION | 2023-08-31 |
| 04035479177850 | BioMonitor IV | BIOTRONIK SE & Co. KG | 2023-05-24 |
| 00763000504519 | AccuRhythm™ AI | MEDTRONIC, INC. | 2021-12-31 |
| 00763000504526 | AccuRhythm™ AI | MEDTRONIC, INC. | 2021-12-31 |
| 00763000504533 | AccuRhythm™ AI | MEDTRONIC, INC. | 2021-12-31 |
| 00763000562632 | Reveal LINQ™ | MEDTRONIC, INC. | 2021-09-04 |
| 00763000562625 | Reveal LINQ™ | MEDTRONIC, INC. | 2021-09-04 |
| 00763000554002 | LINQ II™ | MEDTRONIC, INC. | 2021-06-14 |
| 00763000162191 | LINQ II™ | MEDTRONIC, INC. | 2020-07-18 |
| 00763000060374 | LINQ II™ | MEDTRONIC, INC. | 2020-07-18 |
| 00802526607103 | LUX-Dx™ Insertable Cardiac Monitor | BOSTON SCIENTIFIC CORPORATION | 2020-07-01 |
| 00802526607363 | myLUX™ Patient Kit with mobile device | BOSTON SCIENTIFIC CORPORATION | 2020-07-01 |
| 00802526607370 | LUX-Dx™ Clinic Assistant Kit with mobile device | BOSTON SCIENTIFIC CORPORATION | 2020-07-01 |
| 00802526607608 | myLUX™ patient app | BOSTON SCIENTIFIC CORPORATION | 2020-07-01 |
| 00643169845749 | Reveal LINQ™ | MEDTRONIC, INC. | 2017-03-10 |
| 04035479149314 | BioMonitor | BIOTRONIK SE & Co. KG | 2016-04-29 |