# K223857: i-STAT G3+ cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Sep 15, 2023 after 266 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
Longest line of descent: 5 generations back to K872888 (1987). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192240: RAPIDPoint 500e Blood Gas System, Siemens Healthcare Diagnostics, Inc. (2020) Summary page 5.

## Most influential descendants
- K244014: i-STAT CG4+ cartridge with the i-STAT 1 System (2025), 0 descendants of its own

## Recalls of this device
- Apr 1, 2026 · Class II · Z-2001-2026: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may r

## Indications for use
The i-STAT G3+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (P02), and partial pressure of carbon dioxide (PC02) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings. pH, P02, and PC02 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances.

Source page: https://510kreport.com/device/K223857
Methodology: https://510kreport.com/methodology