510(k) · Cleared
ClearedS-Patch Ex Wearable ECG Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellysis Corp. · DSH Recorder, Magnetic Tape, Medical
Cleared on Aug 30, 2023 as substantially equivalent to K171410 (Braemar Manufacturing, LLC, 2018) after a 118-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 30, 2023
- Review
- 118 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950944 (1996). 8 ancestors in all. 3 later devices descend from it, 3 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 backK171410 ePatchBraemar Manufacturing, LLC · 2018
- This deviceK231289 S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023
- Descendant · cites it directly · 0 of its ownK253384 mobiCARE Cardiac Monitoring System (mobiCARE-MC200M…Seers Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252389 Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK233906 S-Patch (S-Patch ExL)Wellysis Corp. · 2024
Most influential descendants
Showing 3 of 3 · See all- K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…Seers Technology Co., Ltd. · 2026 · cites it directly0descendants
- K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026 · cites it directly0descendants
- K233906S-Patch (S-Patch ExL)Wellysis Corp. · 2024 · 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 | K171410 | ePatch | Braemar Manufacturing, LLC | 2018 | — |
| 0 (this device) | K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023 | — |
| +1 | K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML… | Seers Technology Co., Ltd. | 2026 | — |
| +1 | K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | 2026 | — |
| +1 | K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 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 |
|---|---|---|---|
| * | K171410 | ePatchSummary page 4…fication of Predicate Device(s) The identified predicate device within this submission is shown as following: Predicate Device 510(k) Number K171410 Trade/Device/Model Name ePatch® Device Classification Name Medical magnetic tape recorder Regulation… | 2018 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K253384 (Seers Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171410.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
S-Patch Ex wearable ECG patch 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. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231289: S-Patch Ex Wearable ECG Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231289
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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