510(k) · Cleared
ClearedEcg Minimonitor, Model CG-5000
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 Oct 7, 1999 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 56 later devices descend from it.
- Decided
- Oct 7, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 1 citing it directly.
- This deviceK992696 Ecg Minimonitor, Model CG-5000Card Guard Scientific Survival, Ltd. · 1999
- Descendant · cites it directly · 55 of its ownK060766 Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Omron Healthcare, Inc. · 2006
- Descendant · 2 generations on · 37 of its ownK093872 Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2010
- Descendant · 2 generations on · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
- Descendant · 3 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- Descendant · 4 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K060766Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Omron Healthcare, Inc. · 2006 · cites it directly55descendants
- K093872Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2010 · 2 generations on37descendants
- K111438REKA E100Reka Pte, Ltd. · 2011 · 2 generations on32descendants
- K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 3 generations on31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992696 | Ecg Minimonitor, Model CG-5000 | Card Guard Scientific Survival, Ltd. | 1999 | — |
| +1 | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801 | Omron Healthcare, Inc. | 2006 | — |
| +2 | K093872 | Handheld Ecg Monitor, Model MD100 | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| +2 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| +3 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| +4 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (56)
See all 561 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801 | 2006 | 55 |
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, K060766 (Omron Healthcare, Inc., 2006) has gone furthest, with 55 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-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992696: Ecg Minimonitor, Model CG-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992696
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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