510(k) · Cleared

Cleared

Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720

K981394510(k) TraditionalCleared Sep 28, 1998164-day reviewClass II21 CFR 870.2920

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

Braemar Corp. · DXH Transmitters And Receivers, Electrocardiograph, Telephone

Cleared on Sep 28, 1998 as substantially equivalent to K923930 (Tz Medical, Inc., 1992) after a 164-day review. Its family tree reaches back 1 generation to 1992. 51 later devices descend from it.

Decided: Sep 28, 1998
Review: 164 days
Class: Class II
Product code: DXH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923930 (1992). 51 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
This deviceK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
Descendant · cites it directly · 42 of its ownK042022 E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004
Descendant · 2 generations on · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
Descendant · 3 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
Descendant · 4 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
Descendant · 5 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2000high 6 (2026) · low 0 (2001)2026

Most influential descendants

Showing 5 of 51 · See all

K042022E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004 · cites it directly42descendants
K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · 2 generations on40descendants
K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · 3 generations on38descendants
K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 4 generations on30descendants
K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 5 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923930	Electrocardiograph Transmitter	Tz Medical, Inc.	1992	—
0 (this device)	K981394	Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720	Braemar Corp.	1998	—
+1	K042022	E-Tac EX-1000 Electrocardiographic Event Recorder	Datrix, Inc. Dba of Jon Barron, Inc.	2004	—
+2	K090696	Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System	Corventis, Inc.	2009	—
+3	K091971	Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)…	Corventis, Inc.	2009	—
+4	K111917	Nuvant, Mobile Cardiac Telemetry	Corventis, Inc.	2011	—
+5	K113372	Nuvant, Mobilc Cardiac Telemetry	Corventis, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2003	1	0
2004	1	0
2006	1	0
2007	1	0
2009	2	0
2010	2	0
2011	3	0
2012	2	0
2014	3	0
2015	1	0
2016	3	0
2017	3	0
2018	2	0
2019	3	0
2021	1	0
2022	2	0
2023	4	0
2024	5	0
2025	4	0
2026	6	0

FIG. 1 — Lineage of K981394, 1992–2026Source: 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 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

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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	Applicant	Decided	Recalls
*	K923930	Electrocardiograph Transmitter Summary page 4 …ows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic. Substantially Equivalent (SE) To: Braemar ER300 Series 510(k) # K923930 ¢ Comparison To The SE Device: Attribute ER700 Series ER300 Series Liquid Crystal Display Yes No (LCD) Looping memory Yes . Yes M…	Tz Medical, Inc.	1992	—

Also cleared against K923930: 4 other devices →

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K042022	E-Tac EX-1000 Electrocardiographic Event Recorder	Datrix, Inc. Dba of Jon Barron, Inc.	2004	42
K030856	ER800 Series Ecg Event Recorder	Braemar Corp.	2003	6
K992584	PE 501 PC-Ecg Monitor	Nhe Corp.	2000	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?

Its one ancestor has no recall.
Of its descendants, K042022 (Datrix, Inc. Dba of Jon Barron, Inc., 2004) has gone furthest, with 42 descendants of its own.
4 other devices also cite its predicate K923930.

How does its category compare?

All DXH devices

DXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXH

4in 2025

2007high 7 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXH

322in 2025

2007high 322 (2025) · low 41 (2008)2026

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

Recalls per year · DXH

1in 2015

2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DXH

27in 2025

2007high 27 (2025) · low 0 (2007)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?

To record infrequent and elusive ECG heart arrhythmia data. Once an event is recorded, patients transmit the recorded ECG data over the telephone. Or, as an alternative, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic.

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/K981394 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981394: Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981394

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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