# K061640: Integra Mobius Multi-Modality Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Jul 27, 2006 after 45 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). 21 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050702: Neurosystems 1TM Monitor, Neurosystems, LLC (2005) Summary page 1.
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 1.

## Most influential descendants
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K173366: NicoletOne (2018), 3 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own

## Indications for use
The Integra MobiusTM Multi-Modality Monitoring System is intended as an adjunct monitor for displaying and recording parameters such as Intracranial Pressure (ICP), Intracranial Temperature (ICT), Cerebral Blood Flow (CBF), Cerebral Perfusion Pressure (CPP), Cerebrovascular Resistance (CVR), Partial Pressure Brain Tissue Oxygen (PbtO 2) and other parameters from primary source bedside monitors for the purpose of treating patients with neurological disorders. The Integra MobiusTM System data is presented both continuously and as trends to be used in concert with other clinical parameters, not as the sole basis for diagnosis.

Source page: https://510kreport.com/device/K061640
Methodology: https://510kreport.com/methodology