# K022638: Neurorecovery Ventricular Catheter & Main Valve Assembly Kit

- Pathway: 510(k) (Traditional)
- Applicant: Neurorecovery, Inc.
- Decided: Oct 31, 2002 after 84 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- 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 K864676 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902257: Codman* External Drainage System II (Eds-II), Codman & Shurtleff, Inc. (1990) Summary page 1.
- K972994: External CSF Drainage Management Systems, Integra Neurocare, LLC (1997) Summary page 1.

## Indications for use
The Neurorecoverym, Inc., Neurorecoverym Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.

Source page: https://510kreport.com/device/K022638
Methodology: https://510kreport.com/methodology