FDA product code MWJ: Electrocardiograph, Ambulatory (Without Analysis)
MWJ is the FDA product code for electrocardiograph, ambulatory (without analysis). It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel. FDA has cleared 64 510(k) submissions under MWJ, 11 in the last five years, from 46 different applicants. The average 510(k) review took 151 days (median 122); 320 days on average over the last three years. FDA has posted 5 recalls for MWJ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class II |
| Regulation | 21 CFR 870.2800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for MWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 252 |
| 2021 | 1 | 178 |
| 2022 | 4 | 291 |
| 2024 | 2 | 364 |
| 2026 | 5 | 277 |
Compare with all 510(k) review times · Search every MWJ clearance
Top MWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| North East Monitoring, Inc. | 5 | 2014-11-25 |
| Getemed Medizin- Und Informationstechnik AG | 4 | 2013-07-26 |
| Mortara Instrument, Inc. | 3 | 2016-02-26 |
| Braemar, Inc. | 3 | 2007-07-24 |
| Braemar Corp. | 3 | 2003-03-28 |
41 more applicants have MWJ clearances. See the full list in Caduvo.
Most recent MWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254119 | Shenzhen Xinyan Medical Technology Co.,ltd. | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | 2026-09-11 | 266 |
| K253529 | Peerbridge Health, Inc. | Peerbridge COR MDx (Cor MDx) | 2026-09-04 | 295 |
| K253562 | Schiller AG | medilogFD | 2026-08-14 | 270 |
| K253384 | Seers Technology Co., Ltd. | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | 2026-06-25 | 268 |
| K252839 | Zywie, Inc. | ZywieZ3 Sensor & Adhesive | 2026-06-18 | 286 |
Recalls for MWJ devices
5 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-11-25.
| Year | Recalls |
|---|---|
| 2020 | 3 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code MWJ?
MWJ is the FDA product code for electrocardiograph, ambulatory (without analysis). It is a Class II device, regulated under 21 CFR 870.2800 and reviewed by the Cardiovascular panel.
What device class is MWJ?
Class II, regulation 21 CFR 870.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MWJ?
Across 64 cleared submissions the average was 151 days from receipt to decision (median 122).
Which companies have the most MWJ clearances?
North East Monitoring, Inc. (5); Getemed Medizin- Und Informationstechnik AG (4); Mortara Instrument, Inc. (3); Braemar, Inc. (3); Braemar Corp. (3).
Have MWJ devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2024-11-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MWJ
- Run a recall and safety report across every MWJ manufacturer
- Watch product code MWJ 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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