# K211559: EasyStat 300

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corporation
- Decided: Jan 27, 2023 after 617 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
Longest line of descent: 1 generation back to K021515 (2002). 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)
- K021515: Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ Analyzer, Medica Corp. (2002) Summary page 4.

## Indications for use
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances. Blood gases (pO2, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Source page: https://510kreport.com/device/K211559
Methodology: https://510kreport.com/methodology