# K984579: Capno Probe a

- Pathway: 510(k) (Traditional)
- Applicant: Optical Sensors, Inc.
- Decided: Dec 21, 2000 after 729 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: 2 generations back to K951094 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951094: Point-of-Care Arterial Blood Gas Monitoring System, Optical Sensors, Inc. (1996) Summary page 1.
- K963935: Olympus Critical Care Monitoring System, Optical Sensors, Inc. (1997) Summary page 1.
- K962638: Tonocap, TC-200 and Accessory Catheters, Instrumentarium Corp. (1997) Summary page 1.

## Most influential descendants
- K212425: MicroTrend System (2024), 0 descendants of its own

## Indications for use
The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K984579
Methodology: https://510kreport.com/methodology