# K240596: Cerebral Autoregulation Index (CAI) Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Oct 16, 2024 after 226 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K941811 (1994). 248 ancestors in all.
No later device cites it as a predicate yet.
1 of 249 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223651: Cerebral Adaptive Index (CAI) Algorithm, Edwards Lifesciences, LLC (2023) Summary page 7.

## Indications for use
Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) Algorithm.

Source page: https://510kreport.com/device/K240596
Methodology: https://510kreport.com/methodology