# K071505: Modification to Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Aug 6, 2007 after 66 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: 5 generations back to K875179 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050720: Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models NS-P, NS-100, Integra Neurosciences (2005) Summary page 1.

## Recalls of this device
- Jan 28, 2008 · Not classified · Z-1191-2008: Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg co

## Indications for use
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/K071505
Methodology: https://510kreport.com/methodology