510(k) · Cleared
ClearedCG-7000DX 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 10, 1999 as substantially equivalent to K942704 (Card Guard Scientific Survival, Ltd., 1994) after a 31-day review. Its family tree reaches back 1 generation to 1994. 25 later devices descend from it.
- Decided
- Dec 10, 1999
- Review
- 31 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942704 (1994). 25 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- This deviceK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- Descendant · cites it directly · 24 of its ownK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- Descendant · 2 generations on · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
- Descendant · 3 generations on · 11 of its ownK152427 PC ECGEdan Instruments, Inc. · 2016
- Descendant · 4 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK082077 BT3/6, BT12Corscience GmbH & Co. KG · 2008
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K052556CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006 · cites it directly24descendants
- K131819PC ECGEdan Instruments, Inc. · 2013 · 2 generations on12descendants
- K152427PC ECGEdan Instruments, Inc. · 2016 · 3 generations on11descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 4 generations on8descendants
- K082077BT3/6, BT12Corscience GmbH & Co. KG · 2008 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942704 | Card Guard, Model CG-7000D Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1994 | — |
| 0 (this device) | K993799 | CG-7000DX Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1999 | — |
| +1 | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +2 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| +3 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| +4 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +2 | K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (1)
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 |
|---|---|---|---|
| * | K942704 | Card Guard, Model CG-7000D Ecg Recorder/TransmitterSummary page 2…aker artifact detection and marking. (11) Patient Cable with 10 lead wires. 3. Substantial Equivalence The CG-7000DX is an enhanced CG-7000D ECG Recorder/Transmitter (K942704). CG- 7000DX is substantially equivalent-to its predicate CG-7000D since both devices have: e The same intended use, and e The… | 1994 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | 2006 | 24 |
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?
- Its one ancestor has no recall.
- Of its descendants, K052556 (Card Guard Scientific Survival, Ltd., 2006) has gone furthest, with 24 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 | — |
What is it indicated for?
CG-7000DX Recorder/Transmitter is a 12 Lead ambulatory electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, which incorporates a recording and transmitting circuitry, graphic LCD, a package of firmware tools and is intended for use by a medical professional:
a. The ECG is recorded and transmitted to a remote receiving station for consultation with a cardiologist.
b. The ECG is recorded and transferred to a PC for viewing and processing.
The Universal IR Adapter is used for conveying data to the remote receiving station or PC.
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/K993799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993799: CG-7000DX Ecg Recorder/Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993799
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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