510(k) · Cleared
ClearedECG SENTINEL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiomedix, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Oct 18, 2017 as substantially equivalent to K141813 (RhythMedix, LLC, 2014) after a 30-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Oct 18, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963725 (1997). 17 ancestors in all, the oldest K960499 (1996). 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 backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 5 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 4 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 3 generations backK083535 Heartrak Smart EcatUniversal Medical, Inc. · 2008
- 2 generations backK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- 1 generation backK141813 Rhythmstar SystemRhythMedix, LLC · 2014
- This deviceK172801 ECG SENTINEL SystemCardiomedix, Inc. · 2017
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 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −5 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −4 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −3 | K083535 | Heartrak Smart Ecat | Universal Medical, Inc. | 2008 | — |
| −2 | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| −1 | K141813 | Rhythmstar System | RhythMedix, LLC | 2014 | — |
| 0 (this device) | K172801 | ECG SENTINEL System | Cardiomedix, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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 |
|---|---|---|---|
| * | K141813 | Rhythmstar SystemSummary page 4…h transmitter and receiver (21 CFR 870.2920) Class: II Product Code: DXH Predicate Device(s): RhythmStar System (K141813) Device Description: Cardiomedix ECG SENTINEL System is a self-use, 2-lead ECG continuous acquisitio… | 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 20 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- None of the 17 ancestors has a recall.
- 3 other devices also cite its predicate K141813.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical…
Read the full statement (194 words)
The SENTINEL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis.
The device continuously records the ECG data and transfers the data to the Server. Upon detection by an ECG analysis algorithm at the Server the recorded cardiac activity is flagged for review by a medical professional.
The data received from the SENTINEL device can be used by another cleared device for arrhythmia analysis, reporting and signal measurements. The SENTINEL System is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretative or diagnostic statements or provide for any life support.
The SENTINEL System is for prescription use only.
User Population:
The SENTINEL is intended for use by adult or children when supervised by an adult.
The Sentinel is intended for use on adults and infants weighing more than 10 kg (22 lbs.).
Intended Operator Profile:
The SENTINEL is intended for home use. The review and analysis of data is intended for use by an appropriately trained medical practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172801: ECG SENTINEL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172801
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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