510(k) · Cleared

Cleared

E-Fax System

K982034510(k) TraditionalCleared Feb 19, 1999254-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

Blakbag, Ltd., Division of Coherent Systems · DXH Transmitters And Receivers, Electrocardiograph, Telephone

Cleared on Feb 19, 1999 as substantially equivalent to K880283 (Paceart, Inc., 1988) and 2 other predicates after a 254-day review. Its family tree reaches back 1 generation to 1988.

Decided: Feb 19, 1999
Review: 254 days
Class: Class II
Product code: DXH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K880283 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK880283 Paceart Pacemaker Patient Test Syst/Tel Opt CPTSPaceart, Inc. · 1988
This deviceK982034 E-Fax SystemBlakbag, Ltd., Division of Coherent Systems · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K880283	Paceart Pacemaker Patient Test Syst/Tel Opt CPTS	Paceart, Inc.	1988	—
0 (this device)	K982034	E-Fax System	Blakbag, Ltd., Division of Coherent Systems	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	1	0

FIG. 1 — Lineage of K982034, 1988–1999Source: 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? (3)

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
*	K880283	Paceart Pacemaker Patient Test Syst/Tel Opt CPTS Summary page 1 …\|l device. The Panel is Cardiovascular 74DXH. PERFORMANCE STANDARDS None established under Section 514 of the Act. PREDICATED DEVICE Paceart System CardioVoice System K880283, : K931296 and K952065, INDICATIONS The E-FAX Pacemaker Services software is designed to provide an additional program director…	Paceart, Inc.	1988	—
*	K931296	Paceart Cardiophone Summary page 1 …The Panel is Cardiovascular 74DXH. PERFORMANCE STANDARDS None established under Section 514 of the Act. PREDICATED DEVICE Paceart System CardioVoice System K880283, : K931296 and K952065, INDICATIONS The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-…	Paceart, Inc.	1993	—
*	K952065	Paceart Cardiovoice Summary page 1 …s Cardiovascular 74DXH. PERFORMANCE STANDARDS None established under Section 514 of the Act. PREDICATED DEVICE Paceart System CardioVoice System K880283, : K931296 and K952065, INDICATIONS The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System t…	Paceart, Inc.	1996	—

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?

None of the 3 ancestors has a recall.

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?

The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips using a pacemaker telephonic transmitter provided to the patient by his/her physician.

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/K982034 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982034: E-Fax System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982034

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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