510(k) · Cleared
ClearedZIO SR ECG Monitoring Service
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 Jun 19, 2015 as substantially equivalent to K142681 (iRhythm Technologies, Inc., 2014) and 2 other predicates after a 190-day review. Its family tree reaches back 6 generations to 1997. 30 later devices descend from it.
- Decided
- Jun 19, 2015
- Review
- 190 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K963725 (1997). 26 ancestors in all, the oldest K881905 (1988). 30 later devices descend from it, 9 citing it directly.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 4 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 3 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- 2 generations backK111438 REKA E100Reka Pte, Ltd. · 2011
- 1 generation backK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- This deviceK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · cites it directly · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
- Descendant · 3 generations on · 6 of its ownK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
- Descendant · 3 generations on · 4 of its ownK190593 Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2019
- Descendant · 4 generations on · 3 of its ownK241197 DeepRhythmAIMedicalgorithmics S.A. · 2024
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · cites it directly18descendants
- K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 2 generations on12descendants
- K210822DeepRhythmAIMedicalgorithmics S.A. · 2022 · 3 generations on6descendants
- K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2019 · 3 generations on4descendants
- K241197DeepRhythmAIMedicalgorithmics S.A. · 2024 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −4 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −3 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −2 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| −1 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| 0 (this device) | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +1 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| +2 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
| +3 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022 | — |
| +3 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2019 | — |
| +4 | K241197 | DeepRhythmAI | Medicalgorithmics S.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | K142681 | ZEUS (ZIO ECG Utilization Service) SystemSummary page 5…SR) Electrocardiogram (ECG) Monitoring Service Generic/CommonName: Medicalmagnetictaperecorder PREDICATEDEVICE(S) ZEUS(ZIOECGUtilizationServices)System[K142681] ZIOPATCH[K121319] EPIMINI[K121628] Page 2 o… | 2014 |
| * | K121319 | Zio PatchSummary page 5…(ECG) Monitoring Service Generic/CommonName: Medicalmagnetictaperecorder PREDICATEDEVICE(S) ZEUS(ZIOECGUtilizationServices)System[K142681] ZIOPATCH[K121319] EPIMINI[K121628] Page 2 of 4… | 2012 |
| * | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Summary page 5…rvice Generic/CommonName: Medicalmagnetictaperecorder PREDICATEDEVICE(S) ZEUS(ZIOECGUtilizationServices)System[K142681] ZIOPATCH[K121319] EPIMINI[K121628] Page 2 of 4 4… | 2013 |
What descends from it? (30)
See all 309 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163512 | Zio AT ECG Monitoring System | 2017 | 18 |
| K203638 | AT-Patch ECG Analysis System | 2022 | 1 |
| K173461 | ECG recorder and Arrhythmia Detector | 2018 | 1 |
| K171936 | Peerbridge Cor (TM) System | 2017 | 1 |
| K232670 | HiCardi+ H100 | 2024 | 0 |
| K223049 | CardioSTAT® ECG Test Solution | 2023 | 0 |
| K210179 | QOCA Portable ECG Monitoring Device | 2022 | 0 |
| K202456 | M5 Recorder | 2020 | 0 |
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | 2017 | 0 |
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 18 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K163512 (iRhythm Technologies, Inc., 2017) has gone furthest, with 18 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. 2015, 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® SR ECG Monitoring Service is intended to capture, analyze, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics…
Read the full statement (109 words)
The ZIO® SR ECG Monitoring Service is intended to capture, analyze, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143513: ZIO SR ECG Monitoring Service.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143513
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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