510(k) Report

510(k) · Cleared

Cleared

Electrocardiograph Transmitter

K923930510(k) TraditionalCleared Oct 21, 199277-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

Tz Medical, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone

Cleared on Oct 21, 1992 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 81 later devices descend from it.

Decided
Oct 21, 1992
Review
77 days
Class
Class II
Product code
DXH
Recalls
None
Predicates
0

81 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared1998: 1 descendant cleared1997: 2 descendants cleared1999: 2 descendants cleared2011: 3 descendants cleared2009: 3 descendants cleared2007: 2 descendants cleared2001: 1 descendant cleared2000: 1 descendant cleared2003: 1 descendant cleared2025: 7 descendants cleared2002: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2012: 3 descendants cleared2020: 2 descendants cleared2014: 3 descendants cleared2013: 1 descendant cleared2016: 4 descendants cleared2018: 5 descendants cleared2015: 3 descendants cleared2017: 3 descendants cleared2019: 3 descendants cleared2022: 5 descendants cleared2026: 6 descendants cleared2023: 6 descendants cleared2024: 5 descendants cleared2021: 2 descendants cleared1990200020102020
  1. This deviceK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
  2. Descendant · cites it directly · 51 of its ownK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
  3. Descendant · cites it directly · 42 of its ownK042022 E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004
  4. Descendant · 2 generations on · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  5. Descendant · 3 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  6. Descendant · 4 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

1997: 21998: 11999: 22000: 12001: 12002: 12003: 12004: 22006: 12007: 22008: 12009: 32010: 22011: 32012: 32013: 12014: 32015: 32016: 42017: 32018: 52019: 32020: 22021: 22022: 52023: 62024: 52025: 72026: 6
1997high 7 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 81 · See all
  • K981394Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998 · cites it directly51descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923930Electrocardiograph TransmitterTz Medical, Inc.1992—
+1K981394Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp.1998—
+1K042022E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc.2004—
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.2009—
+3K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)…Corventis, Inc.2009—
+4K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
199920
200010
200110
200210
200310
200420
200610
200720
200810
200930
201020
201130
201230
201310
201430
201530
201640
201730
201850
201930
202020
202120
202250
202360
202450
202570
202660
FIG. 1 — Lineage of K923930, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K981394Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp.199851
K042022E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc.200442
K972649Cardiocall Cardiac Event RecorderReynolds Medical, Ltd.199719
K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc.19996
K973141Heart Access Plus Cardiac Event RecorderPaceart, Inc.19971

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, K981394 (Braemar Corp., 1998) has gone furthest, with 51 descendants of its own.

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

2007: 32008: 72009: 22010: 22012: 12013: 32014: 62015: 42016: 12017: 52018: 42019: 62020: 52021: 32022: 42023: 12025: 42026 (partial year): 1
2007high 7 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXH

322in 2025

2007: 202 days median2008: 41 days median2013: 206 days median2014: 186 days median2015: 142 days median2017: 150 days median2018: 294 days median2019: 177 days median2020: 141 days median2021: 107 days median2022: 150 days median2025: 322 days median
2007high 322 (2025) · low 41 (2008)2026

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

Recalls per year · DXH

1in 2015

2008: 42011: 32015: 12026 (partial year): 1
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

2009: 12010: 42011: 12012: 12013: 12014: 12016: 52017: 42020: 52021: 22022: 62023: 42024: 22025: 27
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007320200
200874140
20092—01
20102—04
20110—31
20121—01
2013320601
2014618601
2015414210
20161—05
2017515004
2018429400
2019617700
2020514105
2021310702
2022415006
20231—04
20240—02
20254322027
20261—1—

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https://510kreport.com/device/K923930 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923930: Electrocardiograph Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923930

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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