510(k) · Cleared
ClearedEasyra Sodium Assay, Easyra Potassium Assay, Easyra Chloride Assay, Easyra Carbon Dioxide Assay Model Cat NO. 5423 & 520
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medica Corp. · JGS Electrode, Ion Specific, Sodium
Cleared on Jan 14, 2011 after a 296-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 14, 2011
- Review
- 296 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na') in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte…
Read the full statement (249 words)
The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na') in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
For in vitro diagnostic use only.
The EasyRA potassium test is intended for the quantitative determination of potassium ions (K)5 in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
For in vitro diagnostic use only.
The EasyRA chloride test is intended for the quantitative determination of chloride ions (CI-) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
For in vitro diagnostic use only.
The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
For in vitro diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100829 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100829: Easyra Sodium Assay, Easyra Potassium Assay, Easyra Chloride Assay, Easyra Carbon Dioxide Assay Model Cat NO. 5423 & 520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100829
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026