# K992226: XDS External CSF Drainage and Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Aug 4, 2000 after 399 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: 2 generations back to K902257 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984053: Becker External Drainage and Monitoring System, Medtronic PS Medical (1999) Summary page 1.

## Indications for use
Allows for drainage and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.

Source page: https://510kreport.com/device/K992226
Methodology: https://510kreport.com/methodology