# K192289: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit

- Pathway: 510(k) (Traditional)
- Applicant: Irras USA, Ltd.
- Decided: Nov 15, 2019 after 84 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: 4 generations back to K011812 (2001). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171880: IRRAflow CNS System, Irras, Inc. (2018) Summary page 4.

## Most influential descendants
- K200807: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2020), 2 descendants of its own
- K222471: IRRAflow Active Fluid Exchange System (AFES) (2022), 1 descendant of its own
- K231664: IRRAflow Active Fluid Exchange System (AFES) (2023), 0 descendants of its own

## Indications for use
The use of IRRAflow® CNS 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/K192289
Methodology: https://510kreport.com/methodology