# K980380: Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite MS

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Ltd.
- Decided: Jul 14, 1999 after 527 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: 2 generations back to K813459 (1982). 9 ancestors in all.
27 later devices descend from it; 3 cite 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)
- K953893: Paratrend 7 Intravascular Blood Gas Monitoring System, Biomedical Sensors, Inc. (1997) Summary page 2.
- K962928: Combined Intracranial Pressure-Temperature Sensing System (Icp/), Camino Neurocare, Inc. (1996) Summary page 2.
- K914479: Microsensor Intracranial Pressure Transducer, Codman & Shurtleff, Inc. (1994). Our OCR of the scanned summary read K914497, FDA’s number for Biopsy Forceps (Surgitek Medical Engineering Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Microsensor Intracranial Pressure Transducer”.
- K896515: Laserflo Blood Perfusion Monitor, Model BPM2, Tsi, Inc. (1990) Summary page 2.

## Most influential descendants
- K050702: Neurosystems 1TM Monitor (2005), 17 descendants of its own
- 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

## Indications for use
The CODMAN Neurotrend Cerebral Tissue Monitoring System measures intracranial oxygen, carbon dioxide, pH and temperature, and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion and metabolic acidosis/alkalosis status of cerebral tissue local to sensor placement. Because the Neurotrend values are relative within an individual, the Neurotrend should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia/ischaemia is a concern.

Source page: https://510kreport.com/device/K980380
Methodology: https://510kreport.com/methodology