MXD — Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Class II
FDA product code MXD covers "Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)", a Class II medical device regulated under 21 CFR 870.1025. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261074 | biotronik | BIOMONITOR IV (471155) | May 1, 2026 |
| 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 |