510(k) · Cleared
ClearedZywieZ3 Sensor & Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zywie, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jun 18, 2026 as substantially equivalent to K210758 (Medicalgorithmics S.A., 2022) after a 286-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jun 18, 2026
- Review
- 286 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 backK163535 my Patch slDms-Service, LLC · 2017
- 1 generation backK210758 Q PatchMedicalgorithmics S.A. · 2022
- This deviceK252839 ZywieZ3 Sensor & AdhesiveZywie, Inc. · 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 | K163535 | my Patch sl | Dms-Service, LLC | 2017 | — |
| −1 | K210758 | Q Patch | Medicalgorithmics S.A. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K210758 | Q PatchSummary page 5…ss II Classification Product Code MWJ Legally marketed Predicate Device Predicate Device Device Name Q Patch 510(K) No K210758 Regulation No 21 CFR 870.2800 Product Classification Code MWJ Company Name Medicalgorith… | 2022 |
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 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
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?
The ZywieZ3 Sensor is a wireless device intended for use by healthcare professionals to record and display physiological data for patients requiring outpatient cardiac monitoring, both at home and in healthcare settings. When used with the ZywieZ3 Adhesive, the device captures electrocardiogram (ECG) data and wirelessly transmits it to a separate device- such as a mobile phone- for storage, display, and transmission. This is an ambulatory, continuous…
Read the full statement (114 words)
The ZywieZ3 Sensor is a wireless device intended for use by healthcare professionals to record and display physiological data for patients requiring outpatient cardiac monitoring, both at home and in healthcare settings. When used with the ZywieZ3 Adhesive, the device captures electrocardiogram (ECG) data and wirelessly transmits it to a separate device- such as a mobile phone- for storage, display, and transmission.
This is an ambulatory, continuous recording system designed for general patient care. It is not intended for critical care patients and does not replace standard clinical monitoring practices. Instead, it provides physiological data recordings for later review by healthcare professionals. The device is not intended to provide real-time interpretative or diagnostic information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252839 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252839: ZywieZ3 Sensor & Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252839
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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