# K071165: Iscalert Sensor System

- Pathway: 510(k) (Traditional)
- Applicant: Alertis Medical AS
- Decided: Nov 7, 2007 after 195 days
- Product code: CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling)
- Device class: 2
- Regulation: 21 CFR 868.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953893 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Cited in the summary but kept off the family tree
- K980308: Echotech 3D Freescan, Echotech 3D Imaging Systems GmbH (1998). Our reading of the summary gave K980308, FDA’s number for Echotech 3D Freescan (Echotech 3D Imaging Systems GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Neurotrend Cerebral Tissue Monitoring System”. Kept off the family tree. Summary page 1.

## Indications for use
The IscAlertTM sensor system measures the partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy. The IscAlertTM sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.

Source page: https://510kreport.com/device/K071165
Methodology: https://510kreport.com/methodology