510(k) · Cleared
ClearedCard Guard, Model CG-7000D Ecg Recorder/Transmitter
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 Dec 5, 1994 after a 180-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Dec 5, 1994
- Review
- 180 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- Descendant · cites it directly · 25 of its ownK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- Descendant · 2 generations on · 24 of its ownK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- Descendant · 3 generations on · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
- Descendant · 4 generations on · 11 of its ownK152427 PC ECGEdan Instruments, Inc. · 2016
- Descendant · 5 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K993799CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999 · cites it directly25descendants
- K052556CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006 · 2 generations on24descendants
- K131819PC ECGEdan Instruments, Inc. · 2013 · 3 generations on12descendants
- K152427PC ECGEdan Instruments, Inc. · 2016 · 4 generations on11descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942704 | Card Guard, Model CG-7000D Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1994 | — |
| +1 | K993799 | CG-7000DX Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1999 | — |
| +2 | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +3 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| +4 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| +5 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993799 | CG-7000DX Ecg Recorder/Transmitter | 1999 | 25 |
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, K993799 (Card Guard Scientific Survival, Ltd., 1999) has gone furthest, with 25 descendants of its own.
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 | — |
https://510kreport.com/device/K942704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942704: Card Guard, Model CG-7000D Ecg Recorder/Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942704
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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