# K973544: Vacu*Med, Gold Edition Carbon Dioxide Gas Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Vacumed, Div. of Vacumetrics, Inc.
- Decided: May 26, 1998 after 250 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: 1 generation back to K922660 (1993). 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)
- K922660: Physio-Dyne Easi - Lab, Physio-Dyne (1993) Summary page 1.

## Indications for use
Intended for measuring the concentration of carbon dioxide in a gas mixture to aid in determining the patient’s ventilatory, circulatory, and metabolic status.

Source page: https://510kreport.com/device/K973544
Methodology: https://510kreport.com/methodology