510(k) · Cleared

Cleared

Auto Detect for Telaheart DR200/E-a

K070014510(k) TraditionalCleared May 25, 2007142-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

North East Monitoring, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)

Cleared on May 25, 2007 as substantially equivalent to K061293 (North East Monitoring, Inc., 2006) and 1 other predicate after a 142-day review. Its family tree reaches back 4 generations to 1992.

Decided: May 25, 2007
Review: 142 days
Class: Class II
Product code: MWJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K923930 (1992). 10 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
3 generations backK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
2 generations backK030856 ER800 Series Ecg Event RecorderBraemar Corp. · 2003
1 generation backK061293 Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006
This deviceK070014 Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K923930	Electrocardiograph Transmitter	Tz Medical, Inc.	1992	—
−3	K981394	Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720	Braemar Corp.	1998	—
−2	K030856	ER800 Series Ecg Event Recorder	Braemar Corp.	2003	—
−1	K061293	Telaheart Digital Recorder	North East Monitoring, Inc.	2006	—
0 (this device)	K070014	Auto Detect for Telaheart DR200/E-a	North East Monitoring, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1999	1	0
2000	1	0
2004	2	0

FIG. 1 — Lineage of K070014, 1992–2007Source: 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 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? (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
*	K061293	Telaheart Digital Recorder Summary page 2 …assification: Class II, 21 CFR 870.2800, MWJ Class Ii, 21 CFR 870.2920, DXH Predicate Device [21 CFR 807.92(a)(3)] * NorthEast Monitoring Telaheart - K061293 * Heartrak Smart AT - K033451 Auto Detect feature compared to Telaheart The subject device (DR200/HE-a and T…	North East Monitoring, Inc.	2006	—
*	K033451	Heartrak Smart at/Heartrak SMART2 Summary page 2 …00, MWJ Class Ii, 21 CFR 870.2920, DXH Predicate Device [21 CFR 807.92(a)(3)] * NorthEast Monitoring Telaheart - K061293 * Heartrak Smart AT - K033451 Auto Detect feature compared to Telaheart The subject device (DR200/HE-a and Telaheart DR200/E-a) is identical to the p…	Universal Medical, Inc.	2004	—
†	K930564	Holter for Windows	North East Monitoring, Inc.	1995	—

Also cleared against K061293: 1 other device →

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 15 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
None of the 10 ancestors has a recall.
1 other device also cites its predicate K061293.

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. 2007, this device’s year, is highlighted.

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	—

What is it indicated for?

The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode. Holter Mode Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation. Event Recorder The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone…

Read the full statement (108 words)

The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.

Holter Mode

Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.

Event Recorder

The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.

The device includes the Auto Detect feature which can be used as a looping event recorder to capture events automatically or when activated by the patient. When one or more events are captured the patient may transmit his/her recordings transtelephonically.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070014 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070014: Auto Detect for Telaheart DR200/E-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070014

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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