Class Class II
Cerebral Autoregulation Index (CAI) Algorithm (K240596)
Description
Cerebral Autoregulation Index (CAI) Algorithm by Edwards Lifesciences, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240596
Clearance Date2024-10-16
Clearance TypeTraditional
Product CodeMUD
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240596
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. Cerebral Autoregulation Index (CAI) Algorithm (K240596) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 |
Trace the full predicate network for K240596
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.