510(k) · Cleared
ClearedSonacolor CD, Model 6300 Cardiac Doppler Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jun 7, 1983 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Jun 7, 1983
- Review
- 91 days
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 this category? 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?
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.
https://510kreport.com/device/K837329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K837329: Sonacolor CD, Model 6300 Cardiac Doppler Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K837329
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026