510(k) · Cleared
ClearedZio Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
iRhythm Technologies, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Feb 6, 2012 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 16 later devices descend from it.
- Decided
- Feb 6, 2012
- Review
- 38 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK113862 Zio PatchiRhythm Technologies, Inc. · 2012
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K113862 | Zio Patch | iRhythm Technologies, Inc. | 2012 | — |
| +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 | — |
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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
- 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. 2012, 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 Zio® Patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113862: Zio Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113862
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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