# K071984: Modification to Cma Cerebral Tissue Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cma Microdialysis AB
- Decided: Jun 27, 2008 after 344 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 K813459 (1982). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020285: Cma Cerebral Tissue Monitoring System, Cma Microdialysis AB (2002) Summary page 1.
- K060554: Cma Cerebral Tissue Monitoring System, Cma Microdialysis AB (2006) Summary page 1.

## Most influential descendants
- K102077: Modification to Cma Cerebral Tissue Monitoring System (2011), 0 descendants of its own

## Indications for use
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, pyruvate, glycerol and glutamate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.

Source page: https://510kreport.com/device/K071984
Methodology: https://510kreport.com/methodology