510(k) · Cleared
ClearedCardiomem CM 3000-12
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 Jul 14, 2005 as substantially equivalent to K004007 (North East Monitoring, Inc., 2001) and 2 other predicates after a 21-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 14, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911097 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| −1 | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| 0 (this device) | K051686 | Cardiomem CM 3000-12 | Getemed Medizin- Und Informationstechnik AG | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 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? (3)
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 |
|---|---|---|---|
| * | K004007 | DR180+OXYSummary page 1…ion: 21 CFR 870.2800, Class 11 Product Code: MWJ Legally Marketed Devices: DR18O+ Halter recorder (K004007, NorthEast Monitoring, Inc.) H12+ Holte… | 2001 |
| * | K021373 | H12+Holter RecorderSummary page 1…8O+ Halter recorder (K004007, NorthEast Monitoring, Inc.) H12+ Holter recorder (K021 373, Mortara Instrument, Inc.) CardiolD+ (R… | 2002 |
| * | K022540 | Cardio ID+(RZ153+)Summary page 1…order (K021 373, Mortara Instrument, Inc.) CardiolD+ (RZ 153+) Halter recorder (K022540, Rozinn Electronics, Inc.) Reason for Submission Premnarket notification (Abbreviate… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K004007.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 3000-12 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (EGG) 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 as stated in the FDA summary.
https://510kreport.com/device/K051686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051686: Cardiomem CM 3000-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051686
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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