# K021515: Easystat PH, PCO2, PO2, HCT, NA+, K+, CA++ Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Jul 16, 2002 after 67 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K211559: EasyStat 300 (2023), 0 descendants of its own

## Recalls of this device
- Dec 31, 2025 · Class II · Z-1370-2026: A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

## Indications for use
The EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PC02 (partial pressure of carbon dioxide), PO2 (partial pressure of oxygen),Hct (Hematocrit), Na' (sodium), K' (potassium), and ea++ (ionized calcium) on whole blood samples from syringes or capillary tubes. This analyzer is used by laboratory trained technicians in the clinical laboratories to aide in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall a1 condition before corrective / therapeutic action is taken.

Source page: https://510kreport.com/device/K021515
Methodology: https://510kreport.com/methodology