# K063376: Easystat PH, PCO2, PO2, HTC, NA, K, CL Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Jun 25, 2007 after 229 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: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EasyStat pH, PCO2, P02, Htc, Na, K,Ca/Cl analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO 2 (partial pressure of carbon dioxide), P0 2 (partial pressure of oxygen), Htc (Hematocrit), Nat (sodium ions), K+ (potassium ions), Catt (ionized calcium) and cr (chloride ions) in whole blood samples from syringes or capillary tubes. pH measurements are used in the diagnosis and treatment of diseases involving imbalance in the acid-base equilibrium in blood. PCO2 measurements are used inthe diagnosis and treatment of diseases involving imbalance inthe partial pressure of carbon dioxide in blood. P02 measurements are used in the diagnosis and treatment of diseases conditions characterized by low or high blood oxygen levels in blood. Hematotric (Htc) measurements are used in the diagnosis and treatment of diseases characterized by erythrocyte imbalances in whole blood. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (ionized) measurements are used to determine the physiologically active form of calcium in blood and establish the patient's calcium metabolism. Chloride measurements are used inthe diagnosis and treatment of electrolyte and metabolic disorders.

Source page: https://510kreport.com/device/K063376
Methodology: https://510kreport.com/methodology