# K962021: Ciba Corning 348 System

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jun 24, 1996 after 32 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
Longest line of descent: 1 generation back to K933373 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933373: Ciba Corning 300 Series System, Ciba Corning Diagnostics Corp. (1993) Summary page 1.

## Most influential descendants
- K033060: Calibrating Material, Calibrating Standards (2004), 0 descendants of its own

## Indications for use
The Ciba Corning 348 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

Source page: https://510kreport.com/device/K962021
Methodology: https://510kreport.com/methodology