510(k) · Cleared
Clearedmy Patch sl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dms-Service, LLC · DSH Recorder, Magnetic Tape, Medical
Cleared on Feb 22, 2017 as substantially equivalent to K160704 (Dms-Service, LLC, 2016) after a 68-day review. Its family tree reaches back 5 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 22, 2017
- Review
- 68 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K950944 (1996). 7 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 4 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 3 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 2 generations backK131190 MypatchDms-Service, LLC · 2013
- 1 generation backK160704 myPatch-sDms-Service, LLC · 2016
- This deviceK163535 my Patch slDms-Service, LLC · 2017
- Descendant · cites it directly · 1 of its ownK210758 Q PatchMedicalgorithmics S.A. · 2022
- Descendant · cites it directly · 1 of its ownK203168 LifeLens Wireless ECG MonitorLifeLens Technologies, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260157 LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252839 ZywieZ3 Sensor & AdhesiveZywie, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK202456 M5 RecorderGlobal Instrumentation, LLC · 2020
Most influential descendants
Showing 5 of 5 · See all- K210758Q PatchMedicalgorithmics S.A. · 2022 · cites it directly1descendant
- K203168LifeLens Wireless ECG MonitorLifeLens Technologies, Inc. · 2021 · cites it directly1descendant
- K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026 · 2 generations on0descendants
- K252839ZywieZ3 Sensor & AdhesiveZywie, Inc. · 2026 · 2 generations on0descendants
- K202456M5 RecorderGlobal Instrumentation, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −4 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −3 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −2 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| −1 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| 0 (this device) | K163535 | my Patch sl | Dms-Service, LLC | 2017 | — |
| +1 | K210758 | Q Patch | Medicalgorithmics S.A. | 2022 | — |
| +1 | K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | 2021 | — |
| +2 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | — |
| +2 | K252839 | ZywieZ3 Sensor & Adhesive | Zywie, Inc. | 2026 | — |
| +1 | K202456 | M5 Recorder | Global Instrumentation, LLC | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K160704 | myPatch-sSummary page 4…Product Code DSH Cardiovascular 3. Predicate Device to Which This is Substantially Equivalent myPatch®s 510(k) 160704 4. Device Description: The myPatch®sl (model # 3000sl) ambulatory electrocardiograph (ECG) recorder is a small, lightwei… | 2016 |
What descends from it? (5)
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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K210758 (Medicalgorithmics S.A., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K160704.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
myPatch®sl 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.
The myPatch®sl is intended for use by Adults and all Pediatric subgroups
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163535 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163535: my Patch sl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163535
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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