MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Class II
FDA Device Classification
Classification Details
- Product Code
- MXD
- Device Class
- Class II
- Regulation Number
- 870.1025
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253516 | abbott medical | Assert-IQ (DM5100) | December 18, 2025 |
| K251221 | abbott | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | September 17, 2025 |
| K252593 | boston scientific corporation | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monit | September 12, 2025 |
| K240693 | medtronic | LINQ II Insertable Cardiac Monitor (ICM) | March 28, 2024 |
| K233562 | medtronic | LINQ II Insertable Cardiac Monitor | December 6, 2023 |
| K233320 | medtronic | LINQ II Insertable Cardiac Monitor (LNQ22) | October 31, 2023 |
| K231328 | boston scientific | LUX-Dx II (M302); LUX-Dx II+ (M312) | August 19, 2023 |
| K230375 | biotronik | BIOMONITOR IV | May 19, 2023 |
| K230553 | medtronic | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | April 26, 2023 |
| K223630 | medtronic | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, Accu | April 5, 2023 |
| K221962 | medtronic | LINQ II Insertable Cardiac Monitor | August 25, 2022 |
| K221856 | biotronik | BIOMONITOR IIIm, BIOMONITOR III | July 27, 2022 |
| K212008 | medtronic | Reveal LINQ Insertable Cardiac Monitor | July 22, 2021 |
| K210484 | medtronic | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | June 11, 2021 |
| K211304 | medtronic | LINQ II Insertable Cardiac Monitor | May 28, 2021 |
| K210608 | boston scientific corporation | LUX-Dx Insertable Cardiac Monitor | May 25, 2021 |
| K201865 | biotronik | Biomonitor III, Biomonitor IIIm | December 8, 2020 |
| K200795 | medtronic | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, | July 3, 2020 |
| K193473 | boston scientific corporation | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Cli | June 26, 2020 |
| K200444 | biotronik | Biomonitor III, Biomonitor IIIm | April 23, 2020 |