# K160412: GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 14, 2016 after 306 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: 9 generations back to K801848 (1980). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133407: Gem Premier 4000, Instrumentation Laboratory CO (2014) Summary page 4.

## Recalls of this device
- Jan 20, 2026 · Class II · Z-1535-2026: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-u

## Indications for use
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH and pO2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO2 from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s acid/base status. pH, pCO2 and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Source page: https://510kreport.com/device/K160412
Methodology: https://510kreport.com/methodology