# K220396: EasyStat 300

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corporation
- Decided: Sep 26, 2023 after 592 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- 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 K963694 (1996). 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)
- K963694: Easylyte Calcium/Chloride Analyzer, Medica Corp. (1996) Summary page 4.

## Indications for use
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte and/or acid-base disturbances. Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Source page: https://510kreport.com/device/K220396
Methodology: https://510kreport.com/methodology