510(k) · Cleared
ClearedQ Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicalgorithmics S.A. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jun 2, 2022 as substantially equivalent to K163535 (Dms-Service, LLC, 2017) after a 444-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Jun 2, 2022
- Review
- 444 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950944 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 5 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 4 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 3 generations backK131190 MypatchDms-Service, LLC · 2013
- 2 generations backK160704 myPatch-sDms-Service, LLC · 2016
- 1 generation backK163535 my Patch slDms-Service, LLC · 2017
- This deviceK210758 Q PatchMedicalgorithmics S.A. · 2022
- Descendant · cites it directly · 0 of its ownK252839 ZywieZ3 Sensor & AdhesiveZywie, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252839ZywieZ3 Sensor & AdhesiveZywie, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −5 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −4 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −3 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| −2 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| −1 | K163535 | my Patch sl | Dms-Service, LLC | 2017 | — |
| 0 (this device) | K210758 | Q Patch | Medicalgorithmics S.A. | 2022 | — |
| +1 | K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K163535 | my Patch slSummary page 5…codes: MWJ Classification: Electrocardiograph, Ambulatory (Without Analysis) - MWJ III. Predicate Device The selected predicate device is: myPatch®sl, K163535 Volume 4 - Page 1 of 7… | 2017 |
| † | K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252839 | ZywieZ3 Sensor & Adhesive | 2026 | 0 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K252839 (Zywie, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K163535.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Medicalgorithmics’ Q Patch is intended to be used by patients who have a demonstrated need for extended cardiac monitoring and patients with symptoms that may be due to cardiac arrhythmias such as, dizziness, lightheadedness, shortness of breath, palpitations, dyspnea (shortness of breath), anxiety, syncope of unknown etiology in which arrhythmias are suspected or need to be excluded. It is indicated for use on adult patients. The sensor records single ECG channel for up to 15 days and can be used on patients with implanted pacemakers but is not intended to record pacemaker activity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210758: Q Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026