510(k) · Cleared

Cleared

Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001

K012241510(k) TraditionalCleared Feb 1, 2002199-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardionet, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Feb 1, 2002 as substantially equivalent to K003707 (Cardionet, 2001) and 1 other predicate after a 199-day review. Its family tree reaches back 1 generation to 1988. 76 later devices descend from it.

Decided: Feb 1, 2002
Review: 199 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K882803 (1988). 2 ancestors in all. 76 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
This deviceK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
Descendant · cites it directly · 75 of its ownK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
Descendant · cites it directly · 73 of its ownK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
Descendant · cites it directly · 67 of its ownK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
Descendant · 2 generations on · 57 of its ownK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
Descendant · 2 generations on · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2005high 8 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 76 · See all

K052240Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005 · cites it directly75descendants
K063222Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004Cardionet, Inc. · 2006 · cites it directly73descendants
K072558Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Cardionet, Inc. · 2007 · cites it directly67descendants
K083287Avivo Mobile Patient Management SystemCorventis, Inc. · 2009 · 2 generations on57descendants
K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · 2 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882803	ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST	Advanced Cardiovascular Systems, Inc.	1988	—
0 (this device)	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	—
+1	K063222	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004	Cardionet, Inc.	2006	—
+1	K072558	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005	Cardionet, Inc.	2007	—
+2	K083287	Avivo Mobile Patient Management System	Corventis, Inc.	2009	—
+2	K090696	Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System	Corventis, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2009	4	0
2010	3	0
2011	2	0
2012	4	0
2013	1	0
2014	4	0
2015	4	0
2016	5	0
2017	3	0
2018	5	0
2019	3	0
2020	5	0
2021	2	0
2022	3	0
2023	5	0
2024	5	0
2025	8	0
2026	6	0

FIG. 1 — Lineage of K012241, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003707	Cardionet Ambulatory Ecg Monitor, Model CN1000A Summary page 1 …rdioNet Arrhythmia Detector which is also referred to as the subject device, is a modification to the CardioNet Ambulatory ECG monitor cleared by FDA under 510(k) number K003707, in May 2001. The subject device includes the addition of an ECG analysis capability that allows detection of cardiac arrhythmia.…	Cardionet	2001	—
*	K882803	ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST Summary page 1 …s)”. 2. Cardiac Telecom Cardiac TeleCom HeartLink Il ECG Arrhythmia detector and Alarm System— Manufactured by Cardiac Telecom, Inc., cleared by FDA under 510(k) number K882803; 870.1025 Procode DSI ‘ECG Arrhythmia detector and alarm”. - 3. Device Description The CardioNet Arrhythmia Detector which is a…	Advanced Cardiovascular Systems, Inc.	1988	—
†	K003576	Q-Tel RMS (Rehabilitation Management System), Model 000503	Quinton, Inc.	2001	1
†	K000882	Datex-Ohmeda CS/3 Telemetry System	Datex-Ohmeda	2000	—

Also cleared against K003707: 2 other devices →

What descends from it? (76)

See all 76

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052240	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002	Cardionet, Inc.	2005	75
K063222	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004	Cardionet, Inc.	2006	73
K072558	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005	Cardionet, Inc.	2007	67

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?

None of the 2 ancestors has a recall.
Of its descendants, K052240 (Cardionet, Inc., 2005) has gone furthest, with 75 descendants of its own.
2 other devices also cite its predicate K003707.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007high 4,352 (2016) · low 64 (2007)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?

Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia. Patients with dizziness or lightheadedness Patients with palpitations Patients with syncope of unknown etiology Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradyarrhythmias and…

Read the full statement (155 words)

Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.

Patients with dizziness or lightheadedness

Patients with palpitations

Patients with syncope of unknown etiology

Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block. This includes post operative monitoring for these rhythms

Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias

Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease

Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias

Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation

Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012241 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012241: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012241

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026