510(k) · Cleared
Recalled · 2012Micromedical 12 Lead Simultaneous Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical Industries, Ltd. · LOS (no longer in FDA’s product-code list)
Cleared on Feb 2, 1999 after a 5-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 1999
- Review
- 5 days
- Product code
- LOS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK990266 Micromedical 12 Lead Simultaneous CableMicromedical Industries, Ltd. · 1999
- Descendant · cites it directly · 2 of its ownK102378 Vectraplexecg System with VectraplexamiVectracor, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK173952 Universal SmartECGVectracor, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK232035 ImpalaAliveCor, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990266 | Micromedical 12 Lead Simultaneous Cable | Micromedical Industries, Ltd. | 1999 | — |
| +1 | K102378 | Vectraplexecg System with Vectraplexami | Vectracor, Inc. | 2011 | — |
| +1 | K173952 | Universal SmartECG | Vectracor, Inc. | 2018 | — |
| +2 | K232035 | Impala | AliveCor, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | — | 12 Lead Simultaneous Cable Named without a submission number |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2012 | Not classified | Z-1315-2012 | Process control | QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102378 (Vectracor, Inc., 2011) has gone furthest, with 2 descendants of its own.
What is it indicated for?
The 12 Lead Simultaneous Cable is used to acquire a patient’s ECG via 10 leads connected to a patient’s chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.
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/K990266 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990266: Micromedical 12 Lead Simultaneous Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990266
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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