510(k) · Cleared
ClearedmyPatch-s
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 Jul 15, 2016 as substantially equivalent to K131190 (Dms-Service, LLC, 2013) after a 123-day review. Its family tree reaches back 4 generations to 1996. 14 later devices descend from it.
- Decided
- Jul 15, 2016
- Review
- 123 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950944 (1996). 6 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 3 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 2 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 1 generation backK131190 MypatchDms-Service, LLC · 2013
- This deviceK160704 myPatch-sDms-Service, LLC · 2016
- Descendant · cites it directly · 7 of its ownK171410 ePatchBraemar Manufacturing, LLC · 2018
- Descendant · cites it directly · 5 of its ownK163535 my Patch slDms-Service, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK231289 S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023
- Descendant · 2 generations on · 2 of its ownK211709 BiotresBiotricity · 2022
- Descendant · 2 generations on · 1 of its ownK210758 Q PatchMedicalgorithmics S.A. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K171410ePatchBraemar Manufacturing, LLC · 2018 · cites it directly7descendants
- K163535my Patch slDms-Service, LLC · 2017 · cites it directly5descendants
- K231289S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023 · 2 generations on3descendants
- K211709BiotresBiotricity · 2022 · 2 generations on2descendants
- K210758Q PatchMedicalgorithmics S.A. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −3 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −2 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −1 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| 0 (this device) | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| +1 | K171410 | ePatch | Braemar Manufacturing, LLC | 2018 | — |
| +1 | K163535 | my Patch sl | Dms-Service, LLC | 2017 | — |
| +2 | K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023 | — |
| +2 | K211709 | Biotres | Biotricity | 2022 | — |
| +2 | K210758 | Q Patch | Medicalgorithmics S.A. | 2022 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K131190 | MypatchSummary page 5…direct ph: (775) 315-0660, fax: (800) 441-3437 Trade Name: myPatch®-s Model #: 3000 Legally Marketed Device: myPatch® Ambulatory ECG Recorder, 510(k) K131190 Classification: 21 CFR 870.2800, Medical Magnetic Tape Recorder, Cardiovascular Panel Device Class: II Product Code… | 2013 |
What descends from it? (14)
See all 142 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 20 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K171410 (Braemar Manufacturing, LLC, 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K131190.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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®s 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®s is intended for use by Adults and all Pediatric subgroups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160704: myPatch-s.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160704
Report an extraction error
Are you the manufacturer?
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