510(k) · Cleared
ClearedMysense Heart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science Corporation · DSH Recorder, Magnetic Tape, Medical
Cleared on Dec 21, 2011 as substantially equivalent to K090363 (iRhythm Technologies, Inc., 2009) and 1 other predicate after a 54-day review. Its family tree reaches back 2 generations to 1996. 16 later devices descend from it.
- Decided
- Dec 21, 2011
- Review
- 54 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950944 (1996). 3 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 1 generation backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- This deviceK113176 Mysense HeartCardiac Science Corporation · 2011
- Descendant · cites it directly · 15 of its ownK131190 MypatchDms-Service, LLC · 2013
- Descendant · 2 generations on · 14 of its ownK160704 myPatch-sDms-Service, LLC · 2016
- Descendant · 2 generations on · 7 of its ownK171410 ePatchBraemar Manufacturing, LLC · 2018
- Descendant · 3 generations on · 5 of its ownK163535 my Patch slDms-Service, LLC · 2017
- Descendant · 3 generations on · 3 of its ownK231289 S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K131190MypatchDms-Service, LLC · 2013 · cites it directly15descendants
- K160704myPatch-sDms-Service, LLC · 2016 · 2 generations on14descendants
- K171410ePatchBraemar Manufacturing, LLC · 2018 · 2 generations on7descendants
- K163535my Patch slDms-Service, LLC · 2017 · 3 generations on5descendants
- K231289S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −1 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| 0 (this device) | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| +1 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| +2 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| +2 | K171410 | ePatch | Braemar Manufacturing, LLC | 2018 | — |
| +3 | K163535 | my Patch sl | Dms-Service, LLC | 2017 | — |
| +3 | K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K090363 | Zio Patch, Model Z100Summary page 1…425-402-2156 (phone) 425-402-2017 (fax) SubstantiallyEquivalent Devices iRhythmn Technologies, Inc. Zio patch K090363 San Francisco, CA Example model Zi100 Braemar Corporation Hal… | 2009 |
| * | K993618 | DXP1000 Holter RecorderSummary page 1…K090363 San Francisco, CA Example model Zi100 Braemar Corporation Halter recorder K993618 Burnsville, MN Example model: Model DXPIOOO ______________________(model… | 1999 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131190 | Mypatch | 2013 | 15 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131190 (Dms-Service, LLC, 2013) has gone furthest, with 15 descendants of its own.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113176: Mysense Heart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113176
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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