# K050702: Neurosystems 1TM Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Neurosystems, LLC
- Decided: May 17, 2005 after 60 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: 4 generations back to K875179 (1988). 16 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 34 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.
- K980380: Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite MS, Diametrics Medical, Ltd. (1999) Summary page 1.

## Most influential descendants
- K061640: Integra Mobius Multi-Modality Monitoring System (2006), 15 descendants of its own
- 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

## Indications for use
The NeuroSystems 1 TM monitor has been designed for use by a qualified neurosurgeon to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical patients. The variables displayed by the NeuroSystems 1TM monitor include intracranial pressure, cerebral Ibood flow, brain tissue oxygen, brain temperature and pH, carbon dioxide and arterial blood pressure, and these are presented both continuously and as trends in these variables, and in the form of relationship graphs. The presentation of both measured variables and the relationships between them is intended as an adjunct to the information provided by existing primary monitors, and the NeuroSystems 1TM monitor should not be used alone as the sole basis for decisions as to diagnosis or therapy.

Source page: https://510kreport.com/device/K050702
Methodology: https://510kreport.com/methodology