FDA product code MXD: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
MXD is the FDA product code for recorder, event, implantable cardiac, (with arrhythmia detection). It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel. FDA has cleared 34 510(k) submissions under MXD, 14 in the last five years, from 6 different applicants. The average 510(k) review took 86 days (median 65); 38 days on average over the last three years. FDA has posted 10 recalls for MXD devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
| Device class | Class II |
| Regulation | 21 CFR 870.1025 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MXD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 66 |
| 2019 | 1 | 122 |
| 2020 | 4 | 126 |
| 2021 | 4 | 62 |
| 2022 | 2 | 40 |
| 2023 | 6 | 73 |
| 2024 | 1 | 15 |
| 2025 | 3 | 71 |
| 2026 | 2 | 29 |
Compare with all 510(k) review times · Search every MXD clearance
Top MXD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic, Inc. | 17 | 2026-08-28 |
| Biotronik, Inc. | 11 | 2026-05-01 |
| Boston Scientific Corporation | 3 | 2025-09-12 |
| ABBOTT MEDICAL | 1 | 2025-12-18 |
| Abbott | 1 | 2025-09-17 |
1 more applicants have MXD clearances. See the full list in Caduvo.
Most recent MXD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262735 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | 2026-08-28 | 28 |
| K261074 | Biotronik, Inc. | BIOMONITOR IV (471155) | 2026-05-01 | 30 |
| K253516 | ABBOTT MEDICAL | Assert-IQ (DM5100) | 2025-12-18 | 36 |
| K251221 | Abbott | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | 2025-09-17 | 149 |
| K252593 | Boston Scientific Corporation | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | 2025-09-12 | 28 |
Recalls for MXD devices
10 product recalls in 7 recall events; 8 initiated in the last five years and 9 still open. Most recent: 2026-08-06.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 5 |
Frequently asked questions
What is FDA product code MXD?
MXD is the FDA product code for recorder, event, implantable cardiac, (with arrhythmia detection). It is a Class II device, regulated under 21 CFR 870.1025 and reviewed by the Cardiovascular panel.
What device class is MXD?
Class II, regulation 21 CFR 870.1025. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXD?
Across 34 cleared submissions the average was 86 days from receipt to decision (median 65).
Which companies have the most MXD clearances?
Medtronic, Inc. (17); Biotronik, Inc. (11); Boston Scientific Corporation (3); ABBOTT MEDICAL (1); Abbott (1).
Have MXD devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2026-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code MXD
- Run a recall and safety report across every MXD manufacturer
- Watch product code MXD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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