FDA Product Code
FDA Product Code MXD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | 2026-08-28 | Special | PDF ↗ |
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | 2026-05-01 | Special | PDF ↗ |
| K253516 | Assert-IQ (DM5100) | ABBOTT MEDICAL | 2025-12-18 | Special | PDF ↗ |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | 2025-09-17 | Traditional | PDF ↗ |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | 2025-09-12 | Special | PDF ↗ |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | 2024-03-28 | Special | PDF ↗ |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2023-12-06 | Special | PDF ↗ |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | 2023-10-31 | Special | PDF ↗ |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023-08-19 | Traditional | PDF ↗ |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | 2023-04-26 | Traditional | PDF ↗ |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | 2023-04-05 | Traditional | PDF ↗ |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2022-08-25 | Traditional | PDF ↗ |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022-07-27 | Special | PDF ↗ |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021-07-22 | Special | PDF ↗ |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | 2021-06-11 | Traditional | PDF ↗ |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2021-05-28 | Special | PDF ↗ |
| K210608 | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | 2021-05-25 | Special | PDF ↗ |
| K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-12-08 | Traditional | PDF ↗ |
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | Medtronic, Inc. | 2020-07-03 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K200444 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020-04-23 | Traditional | PDF ↗ |
| K190548 | BIOMONITOR III, Remote Assistant III | Biotronik, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | Biotronik, Inc. | 2017-06-29 | Special | PDF ↗ |
| K170628 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2017-03-31 | Special | PDF ↗ |
| K162855 | Reveal LINQ | Medtronic, Inc. | 2017-02-23 | Traditional | PDF ↗ |
| K163460 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2017-02-14 | Traditional | PDF ↗ |
| K160809 | Reveal LINQ | Medtronic, Inc. | 2016-05-26 | Special | PDF ↗ |
| K160689 | Reveal LINQ | Medtronic, Inc. | 2016-04-22 | Special | PDF ↗ |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | Biotronik, Inc. | 2016-04-11 | Traditional | PDF ↗ |
| K150614 | Reveal LINQ | Medtronic, Inc. | 2015-08-06 | Traditional | PDF ↗ |
| K143503 | BioMonitor | Biotronik, Inc. | 2015-03-19 | Traditional | PDF ↗ |
| K132960 | BIOMONITOR | Biotronik, Inc. | 2014-06-06 | Traditional | PDF ↗ |
| K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR | Medtronic, Inc. | 2014-02-14 | Traditional | PDF ↗ |
Product code MXD · Class II · Cardiovascular. Data: openFDA.