# K231664: IRRAflow Active Fluid Exchange System (AFES)

- Pathway: 510(k) (Traditional)
- Applicant: Irras USA, Inc.
- Decided: Oct 19, 2023 after 134 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011812 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222471: IRRAflow Active Fluid Exchange System (AFES), Irras USA (2022) Summary page 5.

## Indications for use
The use of IRRAflow Active Fluid Exchange System is indicated when intracranial pressure monitoring is required, and for externally draining intracranial fluid, as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.

Source page: https://510kreport.com/device/K231664
Methodology: https://510kreport.com/methodology