# K973545: Vacu*Med Gold Edition Oxygen Gas Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Vacumed, Div. of Vacumetrics, Inc.
- Decided: May 26, 1998 after 250 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- 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
The indications for use of the Gold Edition VacuMed Oxygen Gas Analyzer are to measure expired Oxygen Gases.

Source page: https://510kreport.com/device/K973545
Methodology: https://510kreport.com/methodology