# K172209: Aura Icp Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Branchpoint Technologies, Inc.
- Decided: May 18, 2018 after 298 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: 5 generations back to K875179 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042728: Camino Slim-Line Intracranial Monitoring System, Novus Monitoring, Ltd. (2004) Summary page 4.

## Indications for use
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

Source page: https://510kreport.com/device/K172209
Methodology: https://510kreport.com/methodology