510(k) · Cleared

Cleared

Cardionet Ambulatory Ecg Monitor, Model CN1000A

K003707510(k) TraditionalCleared May 16, 2001166-day reviewClass II21 CFR 870.2800

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

Cardionet · MWJ Electrocardiograph, Ambulatory (Without Analysis)

Cleared on May 16, 2001 after a 166-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 79 later devices descend from it.

Decided: May 16, 2001
Review: 166 days
Class: Class II
Product code: MWJ
Recalls: None
Predicates: 0

79 later devices descend from it, 3 citing it directly.

This deviceK003707 Cardionet Ambulatory Ecg Monitor, Model CN1000ACardionet · 2001
Descendant · cites it directly · 76 of its ownK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
Descendant · 2 generations on · 75 of its ownK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
Descendant · 2 generations on · 73 of its ownK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
Descendant · 2 generations on · 67 of its ownK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
Descendant · 3 generations on · 57 of its ownK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2002high 8 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 79 · See all

K012241Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001Cardionet, Inc. · 2002 · cites it directly76descendants
K052240Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005 · 2 generations on75descendants
K063222Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004Cardionet, Inc. · 2006 · 2 generations on73descendants
K072558Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Cardionet, Inc. · 2007 · 2 generations on67descendants
K083287Avivo Mobile Patient Management SystemCorventis, Inc. · 2009 · 3 generations on57descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003707	Cardionet Ambulatory Ecg Monitor, Model CN1000A	Cardionet	2001	—
+1	K012241	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001	Cardionet, Inc.	2002	—
+2	K052240	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002	Cardionet, Inc.	2005	—
+2	K063222	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004	Cardionet, Inc.	2006	—
+2	K072558	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005	Cardionet, Inc.	2007	—
+3	K083287	Avivo Mobile Patient Management System	Corventis, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
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 K003707, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MWJ? 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 MWJ device

#1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (79)

See all 79

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

Number	Device	Applicant	Decided	Descendants
K012241	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001	Cardionet, Inc.	2002	76
K032882	Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100	Recom Managed Systems, Inc.	2004	0
K031229	Telzuit Cardiac Monitoring System	Telzuit Technologies, Inc.	2003	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?

Of its descendants, K012241 (Cardionet, Inc., 2002) has gone furthest, with 76 descendants of its own.

How does its category compare?

All MWJ devices

MWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWJ

2in 2024

2007high 5 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWJ

337in 2022

2007high 337 (2022) · low 90 (2010)2026

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

Recalls per year · MWJ

2in 2024

2007high 2 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MWJ

8in 2025

2007high 12 (2020) · low 0 (2007)2025

MAUDE reports naming product code MWJ, 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	5	142	0	0
2008	1	—	0	0
2009	2	—	0	5
2010	3	90	0	0
2011	3	206	0	0
2012	1	—	0	2
2013	3	241	0	4
2014	2	—	0	1
2015	0	—	0	1
2016	2	—	0	1
2017	0	—	0	2
2018	1	—	0	1
2019	0	—	0	4
2020	0	—	0	12
2021	1	—	0	3
2022	4	337	0	6
2023	0	—	0	5
2024	2	—	2	3
2025	0	—	0	8
2026	5	270	0	—

https://510kreport.com/device/K003707 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003707: Cardionet Ambulatory Ecg Monitor, Model CN1000A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003707

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026