510(k) · Cleared
ClearedCardiomem CM 3000-12BT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getemed Medizin- Und Informationstechnik AG · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on May 30, 2007 as substantially equivalent to K052556 (Card Guard Scientific Survival, Ltd., 2006) after a 239-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- May 30, 2007
- Review
- 239 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K942704 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- 2 generations backK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- 1 generation backK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- This deviceK063042 Cardiomem CM 3000-12BTGetemed Medizin- Und Informationstechnik AG · 2007
- Descendant · cites it directly · 0 of its ownK130785 SEER 1000Getemed Medizin- Und Informationstechnik AG · 2013
- Descendant · cites it directly · 0 of its ownK122272 CardiomemGetemed Medizin- Und Informationstechnik AG · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942704 | Card Guard, Model CG-7000D Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | K063042 | Cardiomem CM 3000-12BT | Getemed Medizin- Und Informationstechnik AG | 2007 | — |
| +1 | K130785 | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | 2013 | — |
| +1 | K122272 | Cardiomem | Getemed Medizin- Und Informationstechnik AG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081688 | CardioMem CM 3000-12 Holter recorder Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter Our OCR of the scanned summary read K052558, FDA’s number for VCS, Model S4T (Cycling and Health Tech. Industry R&D Center/Chc). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CE-TO00DX-BT ECG Recorder/Transmitter”. | 2006 |
What descends from it? (2)
2 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 13 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K130785 (Getemed Medizin- Und Informationstechnik AG, 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K052556.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The CardioMem CM 3000-12BT is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath or those that need to be monitored to judge their current cardiac functionality.
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/K063042 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063042: Cardiomem CM 3000-12BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063042
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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