510(k) · Cleared
ClearedCardio Care Ekg-2000 12-Channel Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionet Company, Ltd. · LOS (no longer in FDA’s product-code list)
Cleared on Nov 21, 2001 after a 204-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Nov 21, 2001
- Review
- 204 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011328 Cardio Care Ekg-2000 12-Channel ElectrocardiographBionet Company, Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK023034 Cardiotouch-3000Bionet Company, Ltd. · 2002
Most influential descendants
Showing 1 of 1 · See all- K023034Cardiotouch-3000Bionet Company, Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011328 | Cardio Care Ekg-2000 12-Channel Electrocardiograph | Bionet Company, Ltd. | 2001 | — |
| +1 | K023034 | Cardiotouch-3000 | Bionet Company, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023034 | Cardiotouch-3000 | 2002 | 0 |
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, K023034 (Bionet Company, Ltd., 2002) has gone furthest, with 0 descendants of its own.
https://510kreport.com/device/K011328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011328: Cardio Care Ekg-2000 12-Channel Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011328
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026