FDA product code MXC: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
MXC is the FDA product code for recorder, event, implantable cardiac, (without arrhythmia detection). It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel. FDA has cleared 23 510(k) submissions under MXC, 1 in the last five years, from 10 different applicants. The average 510(k) review took 102 days (median 65). FDA has posted 5 recalls for MXC devices.
Classification
| Field | Value |
|---|---|
| Device name | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) |
| Device class | Class II |
| Regulation | 21 CFR 870.2800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MXC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 164 |
| 2019 | 3 | 79 |
| 2020 | 3 | 76 |
| 2021 | 1 | 29 |
| 2023 | 1 | 104 |
Compare with all 510(k) review times · Search every MXC clearance
Top MXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott (St. Jude Medical) | 5 | 2021-08-13 |
| St Jude Medical | 4 | 2017-11-02 |
| Medtronic Vascular | 4 | 2001-05-04 |
| Abbott | 2 | 2019-10-18 |
| St. Jude Medical, Inc. | 2 | 2017-09-29 |
5 more applicants have MXC clearances. See the full list in Caduvo.
Most recent MXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230286 | ABBOTT MEDICAL | Assert-IQ Insertable Cardiac Monitor | 2023-05-17 | 104 |
| K212206 | Abbott (St. Jude Medical) | Jot Dx Insertable Cardiac Monitor | 2021-08-13 | 29 |
| K202876 | Abbott (St. Jude Medical) | Confirm Rx Insertable Cardiac Monitor | 2020-12-01 | 64 |
| K202888 | Abbott (St. Jude Medical) | Confirm Rx Insertable Cardiac Monitor | 2020-11-23 | 56 |
| K193310 | Abbott (St. Jude Medical) | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | 2020-03-17 | 109 |
Recalls for MXC devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-11-19.
| Year | Recalls |
|---|---|
| 2018 | 4 |
Frequently asked questions
What is FDA product code MXC?
MXC is the FDA product code for recorder, event, implantable cardiac, (without arrhythmia detection). It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel.
What device class is MXC?
Class II, regulation 21 CFR 870.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXC?
Across 23 cleared submissions the average was 102 days from receipt to decision (median 65).
Which companies have the most MXC clearances?
Abbott (St. Jude Medical) (5); St Jude Medical (4); Medtronic Vascular (4); Abbott (2); St. Jude Medical, Inc. (2).
Have MXC devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2018-11-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MXC
- Run a recall and safety report across every MXC manufacturer
- Watch product code MXC 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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