Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
The Implantable Cardiac Event Recorder with Arrhythmia Detection is a subcutaneously implanted monitoring device designed to continuously record cardiac electrical activity and automatically detect arrhythmias. It is used for long-term cardiac monitoring in patients with infrequent or unexplained symptoms such as syncope or palpitations that are difficult to capture with standard ambulatory monitors. Classified as FDA Class 2, it requires 510(k) premarket notification under regulation 870.1025 (Cardiovascular specialty). This device carries an implant flag, reflecting its implanted nature and the associated clinical considerations for patient safety.
Research product code MXD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MXD
- Device Class
- FDA class 2
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 33 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | May 01, 2026 | Substantially Equivalent | Biotronik, Inc. |
| K253516 | Assert-IQ (DM5100) | Dec 18, 2025 | Substantially Equivalent | ABBOTT MEDICAL |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Sep 17, 2025 | Substantially Equivalent | Abbott |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Sep 12, 2025 | Substantially Equivalent | Boston Scientific Corporation |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM) | Mar 28, 2024 | Substantially Equivalent | Medtronic, Inc. |
| K233562 | LINQ II Insertable Cardiac Monitor | Dec 06, 2023 | Substantially Equivalent | Medtronic, Inc. |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | Oct 31, 2023 | Substantially Equivalent | Medtronic, Inc. |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Aug 19, 2023 | Substantially Equivalent | Boston Scientific Corp |
| K230375 | BIOMONITOR IV | May 19, 2023 | Substantially Equivalent | Biotronik, Inc. |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Apr 26, 2023 | Substantially Equivalent | Medtronic, Inc. |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Apr 05, 2023 | Substantially Equivalent | Medtronic, Inc. |
| K221962 | LINQ II Insertable Cardiac Monitor | Aug 25, 2022 | Substantially Equivalent | Medtronic, Inc. |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Jul 27, 2022 | Substantially Equivalent | Biotronik, Inc. |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Jul 22, 2021 | Substantially Equivalent | Medtronic, Inc. |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Jun 11, 2021 | Substantially Equivalent | Medtronic, Inc. |
| K211304 | LINQ II Insertable Cardiac Monitor | May 28, 2021 | Substantially Equivalent | Medtronic, Inc. |
| K210608 | LUX-Dx Insertable Cardiac Monitor | May 25, 2021 | Substantially Equivalent | Boston Scientific Corporation |
| K201865 | Biomonitor III, Biomonitor IIIm | Dec 08, 2020 | Substantially Equivalent | Biotronik, Inc. |
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | Jul 03, 2020 | Substantially Equivalent | Medtronic, Inc. |
| K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US | Jun 26, 2020 | Substantially Equivalent | Boston Scientific Corporation |
| K200444 | Biomonitor III, Biomonitor IIIm | Apr 23, 2020 | Substantially Equivalent | Biotronik, Inc. |
| K190548 | BIOMONITOR III, Remote Assistant III | Jul 05, 2019 | Substantially Equivalent | Biotronik, Inc. |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | Jun 29, 2017 | Substantially Equivalent | Biotronik, Inc. |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | Mar 31, 2017 | Substantially Equivalent | Biotronik, Inc. |
| K162855 | Reveal LINQ | Feb 23, 2017 | Substantially Equivalent | Medtronic, Inc. |
| K163460 | Reveal LINQ Insertable Cardiac Monitor | Feb 14, 2017 | Substantially Equivalent | Medtronic, Inc. |
| K160809 | Reveal LINQ | May 26, 2016 | Substantially Equivalent | Medtronic, Inc. |
| K160689 | Reveal LINQ | Apr 22, 2016 | Substantially Equivalent | Medtronic, Inc. |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | Apr 11, 2016 | Substantially Equivalent | Biotronik, Inc. |
| K150614 | Reveal LINQ | Aug 06, 2015 | Substantially Equivalent | Medtronic, Inc. |
| K143503 | BioMonitor | Mar 19, 2015 | Substantially Equivalent | Biotronik, Inc. |
| K132960 | BIOMONITOR | Jun 06, 2014 | Substantially Equivalent | Biotronik, Inc. |
| K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR | Feb 14, 2014 | Substantially Equivalent | Medtronic, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.