510(k) · Cleared
ClearedmobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seers Technology Co., Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jun 25, 2026 as substantially equivalent to K231289 (Wellysis Corp., 2023) after a 268-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jun 25, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K950944 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 6 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 5 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 4 generations backK131190 MypatchDms-Service, LLC · 2013
- 3 generations backK160704 myPatch-sDms-Service, LLC · 2016
- 2 generations backK171410 ePatchBraemar Manufacturing, LLC · 2018
- 1 generation backK231289 S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023
- This deviceK253384 mobiCARE Cardiac Monitoring System (mobiCARE-MC200M…Seers Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −6 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −5 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −4 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| −3 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| −2 | K171410 | ePatch | Braemar Manufacturing, LLC | 2018 | — |
| −1 | K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023 | — |
| 0 (this device) | K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML… | Seers Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231289 | S-Patch Ex Wearable ECG PatchSummary page 5…MWJ Panel: Cardiovascular 3. PREDICATE DEVICE The predicate device is the S-Patch Ex Wearable ECG Patch, Wellysis Corp, K231289 4. DESCRIPTION OF THE DEVICE mobiCARE-MC200M/mobiCARE-MC200ML/mobiCARE-MC200M7/mobiCARE- MC200ML7 (“mobiCARE-MC200M series”)… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K231289.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
mobiCARE Cardiac Monitoring System is a wearable, ambulatory ECG recorder. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. mobiCARE Cardiac Monitoring System is intended for use by patients 18 years or older. The device is not intended for use with critical care patients or for real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253384: mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253384
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026