510(k) · Cleared
ClearedCardio-Card Interpretation System I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nasiff Assoc., Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Apr 10, 2000 after a 167-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 10, 2000
- Review
- 167 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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’s file for it is a 510(k) statement, which names no predicate.
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 is it indicated for?
The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable. It is intended to be used by or on…
Read the full statement (120 words)
The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.
It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.
It is intended to be used on the adult patient population.
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/K993616 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993616: Cardio-Card Interpretation System I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993616
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026