510(k) · Cleared
ClearedCG-6108 Arrhythmia Ecg Event Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Aug 22, 2006 as substantially equivalent to K963811 (Card Guard Scientific Survival, Ltd., 1996) and 2 other predicates after a 141-day review. Its family tree reaches back 3 generations to 1997. 44 later devices descend from it.
- Decided
- Aug 22, 2006
- Review
- 141 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963725 (1997). 7 ancestors in all, the oldest K963811 (1996). 44 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- This deviceK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- Descendant · cites it directly · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
- Descendant · cites it directly · 17 of its ownK083535 Heartrak Smart EcatUniversal Medical, Inc. · 2008
- Descendant · 2 generations on · 16 of its ownK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- Descendant · 2 generations on · 8 of its ownK141813 Rhythmstar SystemRhythMedix, LLC · 2014
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · cites it directly25descendants
- K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · 2 generations on18descendants
- K083535Heartrak Smart EcatUniversal Medical, Inc. · 2008 · cites it directly17descendants
- K131699Emotion Ecg MobileMega Electronics, Ltd. · 2013 · 2 generations on16descendants
- K141813Rhythmstar SystemRhythMedix, LLC · 2014 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| 0 (this device) | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +1 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| +2 | K081257 | CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2008 | 2 |
| +1 | K083535 | Heartrak Smart Ecat | Universal Medical, Inc. | 2008 | — |
| +2 | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| +2 | K141813 | Rhythmstar System | RhythMedix, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K963811 | Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter DeviceSummary page 2…Equivalence The clearance for the CG-6108 is sought on the grounds of its claimed substantial equivalence (SE) to the following predicate devices: 1.Card Guard's CG-6106 K963811 for its memory loop monitoring principle of operation and the identity of the intended use. 2. Card Guard's CG-6550 K003220… | 1996 |
| * | K003220 | Personal Ecg Transmitter, Model CG-6550Summary page 2…redicate devices: 1.Card Guard's CG-6106 K963811 for its memory loop monitoring principle of operation and the identity of the intended use. 2. Card Guard's CG-6550 K003220 Personal 3-lead ECG Transmitter - for its arrhythmia artifacts detection algorithm (e.g. AF) 3. Card Guard's PMP 4 SelfCheck… | 2000 |
| * | K042254 | PMP4 Selfcheck EcgSummary page 2…se. 2. Card Guard's CG-6550 K003220 Personal 3-lead ECG Transmitter - for its arrhythmia artifacts detection algorithm (e.g. AF) 3. Card Guard's PMP 4 SelfCheck ECG K042254 - for the BT transmission capability and for interfacing and including the PMP 4 Medical Application - the CG proprietary SW… | 2005 |
What descends from it? (44)
See all 442 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K071995 (Card Guard Scientific Survival, Ltd., 2007) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K963811.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 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?
Intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia
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/K060911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060911: CG-6108 Arrhythmia Ecg Event Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060911
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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