# K242974: External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa
- Decided: Jun 20, 2025 after 267 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 K855058 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853365: H-H Fifth Ventricle, Holter-Hausner Intl. (1985) Summary page 5.
- K964923: Codman Lumbar Drainage Catheter Kit, Johnson & Johnson Professionals, Inc. (1997) Summary page 5.

## Indications for use
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).

Source page: https://510kreport.com/device/K242974
Methodology: https://510kreport.com/methodology