# K102077: Modification to Cma Cerebral Tissue Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cma Microdialysis AB
- Decided: Jan 14, 2011 after 175 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: 6 generations back to K813459 (1982). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071984: Modification to Cma Cerebral Tissue Monitoring System, Cma Microdialysis AB (2008) Summary page 1.

## 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 isehemia or hypoxia is a concern.

Source page: https://510kreport.com/device/K102077
Methodology: https://510kreport.com/methodology