Class Class II
SmartCardia 7L Platform (MCT) (K240653)
Description
SmartCardia 7L Platform (MCT) by Smartcardia SA, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240653
Clearance Date2024-10-31
Clearance TypeTraditional
Product CodeQYX
Regulation Number870.1025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240653
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SmartCardia 7L Platform (MCT) (K240653) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023 |
| K160004 | Crosstella OTW | KANEKA Corporation | 2016 |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detectio... | Infobionic, Inc. | 2016 |
Trace the full predicate network for K240653
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.