# K101133: Sensometrics Software

- Pathway: 510(k) (Traditional)
- Applicant: Dpcom AS
- Decided: Nov 18, 2010 after 210 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: 12 generations back to K941811 (1994). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 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.
- K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/), Camino Neurocare, Inc. (1996) Summary page 1.
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 1.

## Indications for use
Sensometries® Software is intended for use by a qualified nurse or physician to display variables from existing legally marketed primary measuring devices used to monitor neurosurgical and neurological patients. The parameters displayed by the Sensometrics® Software include intracranial pressure, arterial blood pressure, oxygen, core/cerebral temperature, and these are continuously trended in charts. The presentation of both measured parameters and the relationships between them is intended as an adjunct to the information provided by existing primary monitors. The Sensometrics®o Software should not be used alone as the sole basis for decisions as to diagnosis or therapy.

Source page: https://510kreport.com/device/K101133
Methodology: https://510kreport.com/methodology