510(k) · Cleared
ClearedCardioSTAT® ECG Test Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icentia, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Mar 22, 2023 as substantially equivalent to K143513 (iRhythm Technologies, Inc., 2015) after a 174-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Mar 22, 2023
- Review
- 174 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963725 (1997). 27 ancestors in all, the oldest K881905 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 5 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 4 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- 3 generations backK111438 REKA E100Reka Pte, Ltd. · 2011
- 2 generations backK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- 1 generation backK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- This deviceK223049 CardioSTAT® ECG Test SolutionIcentia, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −6 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −5 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −4 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −3 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| −2 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| −1 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| 0 (this device) | K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K143513 | ZIO SR ECG Monitoring ServiceSummary page 4…trols have been issued for devices with product codes DSH, DQK. 5.3. PREDICATE DEVICE(S) Zio® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service, [K143513] Reference device: CarnationTM Ambulatory Monitor Model 3000, [K143067] The predicates have not been subject to a d… | 2015 |
| † | K143067 | Carnation Ambulatory Monitor | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- None of the 27 ancestors has a recall.
- 8 other devices also cite its predicate K143513.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 CardioSTAT ECG Test Solution is intended to capture, analyze, and report symptomatic and/or continuous ECG information for long-term ambulatory monitoring (up to 14 days). It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms, such as palpitations, shortness of breath, dizziness, lightheadedness, presyncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm annotation. The report does not contain diagnostic interpretation; the report is provided for review to 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/K223049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223049: CardioSTAT® ECG Test Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223049
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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