# K212425: MicroTrend System

- Pathway: 510(k) (Traditional)
- Applicant: Exostat Medical, Inc.
- Decided: Nov 7, 2024 after 1,191 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951094 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984579: Capno Probe a, Optical Sensors, Inc. (2000) Summary page 5.

## Indications for use
The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status. The MicroTrend Monitor provides trending information on tissue POMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.

Source page: https://510kreport.com/device/K212425
Methodology: https://510kreport.com/methodology