# K050720: Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models NS-P, NS-100

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences
- Decided: May 11, 2005 after 51 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
Longest line of descent: 4 generations back to K875179 (1988). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013930: Neurosensor, Novus Monitoring, Ltd. (2002) Summary page 1.

## Most influential descendants
- K071505: Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring System (2007), 0 descendants of its own

## Recalls of this device
- Sep 8, 2005 · Not classified · Z-0339-06: Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 h

## Indications for use
The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

Source page: https://510kreport.com/device/K050720
Methodology: https://510kreport.com/methodology