# K822864: Intracranial Pressure Monitoring Device

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Nov 16, 1982 after 50 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051599: Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure Evaluation and Relief (Ciper) Kit (2005), 0 descendants of its own

## Recalls of this device
- Nov 18, 2005 · Not classified · Z-0811-06: The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.

Source page: https://510kreport.com/device/K822864
Methodology: https://510kreport.com/methodology