# K924758: Dmi Blood Gas Analyzer/Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Medical, Inc.
- Decided: Dec 3, 1992 after 71 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 14, 2003 · Not classified · Z-1072-03: An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

Source page: https://510kreport.com/device/K924758
Methodology: https://510kreport.com/methodology