510(k) · Cleared
ClearedCardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardionet, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 25, 2006 as substantially equivalent to K052240 (Cardionet, Inc., 2005) and 1 other predicate after a 154-day review. Its family tree reaches back 3 generations to 1988. 8 later devices descend from it.
- Decided
- Apr 25, 2006
- Review
- 154 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K882803 (1988). 6 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 2 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 1 generation backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- This deviceK053263 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK153473 Braemar Telemetry Patch SystemBraemar Manufacturing, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK133753 Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010 · cites it directly7descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 2 generations on2descendants
- K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC · 2016 · 2 generations on1descendant
- K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014 · 2 generations on1descendant
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −2 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −1 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| 0 (this device) | K053263 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003 | Cardionet, Inc. | 2006 | — |
| +1 | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | Cardionet, Inc. | 2010 | — |
| +2 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +2 | K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | 2016 | — |
| +2 | K133753 | Mome Ecg Continuous Detection and Arrhythmia Detector | Infobionic, Inc. | 2014 | — |
| +3 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 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? (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 |
|---|---|---|---|
| * | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Summary page 1…al Controls Predicate Device The predicate devices selected are as follows: 1. CardioNet Ambulatory ECG Monitor, cleared by FDA under 510(k) number K052240; 870.1025 Procode DSI "Arrhythmia Detector and Alarm" 2. Century Series TM Halter Scanner System, Model C3000IC2000ICl1000… | 2005 |
| * | K024323 | Century Series Holter Scanner System, Models C3000, C2000 and C1000Summary page 1…2. Century Series TM Halter Scanner System, Model C3000IC2000ICl1000 manufactured by Biomedical Systems Corporation cleared by FDA under 510O(k) number K024323; 870:2800 Product Code MLO 'Medical Magnetic Tape Recorder' Device Description The CardioNet ECG Monitor with Arrhy… | 2003 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | 2010 | 7 |
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 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K093288 (Cardionet, Inc., 2010) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K052240.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block…
Read the full statement (259 words)
The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:
1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease
2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms
4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs b) monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischenmia, possibly secondary to atrial fibrillation or atrial flutter
8. Patients requiring measurement, analysis and reporting of the OT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053263: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053263
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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