# K946206: Ciba Corning 8-- Series CO-Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jan 30, 1995 after 40 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974784: Avl Opti Critical Care Analyzer (1998), 5 descendants of its own
- K984299: Avl Opti Critical Care Analyzer (1998), 4 descendants of its own
- K020616: Bayer Rapidpoint 405 System (2002), 2 descendants of its own
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own
- K131126: Opti Cca-TS2 (2013), 1 descendant of its own

Source page: https://510kreport.com/device/K946206
Methodology: https://510kreport.com/methodology