510(k) · Cleared
ClearedCG-7000DX-BT 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 Jan 9, 2006 as substantially equivalent to K993799 (Card Guard Scientific Survival, Ltd., 1999) after a 115-day review. Its family tree reaches back 2 generations to 1994. 24 later devices descend from it.
- Decided
- Jan 9, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942704 (1994). 24 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- 1 generation backK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- This deviceK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- Descendant · cites it directly · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
- Descendant · 2 generations on · 11 of its ownK152427 PC ECGEdan Instruments, Inc. · 2016
- Descendant · 3 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK082077 BT3/6, BT12Corscience GmbH & Co. KG · 2008
- Descendant · 4 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K131819PC ECGEdan Instruments, Inc. · 2013 · cites it directly12descendants
- K152427PC ECGEdan Instruments, Inc. · 2016 · 2 generations on11descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 3 generations on8descendants
- K082077BT3/6, BT12Corscience GmbH & Co. KG · 2008 · cites it directly6descendants
- K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +1 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| +2 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| +3 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +1 | K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008 | — |
| +4 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 |
|---|---|---|---|
| * | K993799 | CG-7000DX Ecg Recorder/TransmitterSummary page 2…Safety and Effectiveness 4. Substantial Equivalence CGj-70000X-BT is substantially equivalent to Card Guard CG-7000DX, legally marketed uinder 510(k) premarket clearance k993799 and resembles PMP 4 SelfCheckTM FC(' k042254 in the use of the Bitietooth method and protocol. CG-7000DX-BT and CG-7000DX have th… | 1999 |
| † | K042254 | PMP4 Selfcheck Ecg | 2005 |
What descends from it? (24)
See all 244 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 12 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131819 (Edan Instruments, Inc., 2013) has gone furthest, with 12 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?
12-Lead electrocardiograph capable of recording and transmitting up to 40 standard ECGs for the purpose of cardiac monitoring and diagnosis, incorporates recording/ 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 remote hand held device/PC/printer for viewing and processing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052556: CG-7000DX-BT 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/K052556
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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