510(k) · Cleared

Cleared

Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter Device

K963811510(k) TraditionalCleared Dec 4, 199672-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

Card Guard Scientific Survival, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone

Cleared on Dec 4, 1996 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 76 later devices descend from it.

Decided: Dec 4, 1996
Review: 72 days
Class: Class II
Product code: DXH
Recalls: None
Predicates: 0

76 later devices descend from it, 2 citing it directly.

This deviceK963811 Card Guard Model CG-6106 Personal Electrocardiogram (Ecg)…Card Guard Scientific Survival, Ltd. · 1996
Descendant · cites it directly · 44 of its ownK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
Descendant · cites it directly · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
Descendant · 2 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
Descendant · 3 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
Descendant · 2 generations on · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2006high 7 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 76 · See all

K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006 · cites it directly44descendants
K111438REKA E100Reka Pte, Ltd. · 2011 · cites it directly32descendants
K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 2 generations on31descendants
K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 3 generations on30descendants
K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · 2 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K963811	Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter Device	Card Guard Scientific Survival, Ltd.	1996	—
+1	K060911	CG-6108 Arrhythmia Ecg Event Recorder	Card Guard Scientific Survival, Ltd.	2006	—
+1	K111438	REKA E100	Reka Pte, Ltd.	2011	—
+2	K121628	Epi Mini Ecg Portable Health Monitoring System (Epi Mini)	Epi Mobile Health Solutions (S) Pte, Ltd.	2013	—
+3	K143513	ZIO SR ECG Monitoring Service	iRhythm Technologies, Inc.	2015	—
+2	K071995	CG-6108 Continuous Ecg Monitor and Arrhythmia Detector	Card Guard Scientific Survival, Ltd.	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2009	1	0
2010	4	0
2011	5	0
2013	2	0
2014	3	0
2015	5	0
2016	5	0
2017	6	0
2018	3	0
2019	2	0
2020	3	0
2021	2	0
2022	4	0
2023	6	0
2024	7	0
2025	7	0
2026	7	0

FIG. 1 — Lineage of K963811, 1996–2026Source: 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 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?

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

What descends from it? (76)

See all 76

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

Number	Device	Applicant	Decided	Descendants
K060911	CG-6108 Arrhythmia Ecg Event Recorder	Card Guard Scientific Survival, Ltd.	2006	44
K111438	REKA E100	Reka Pte, Ltd.	2011	32

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, K060911 (Card Guard Scientific Survival, Ltd., 2006) has gone furthest, with 44 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

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	—

https://510kreport.com/device/K963811 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963811: Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963811

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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