510(k) · Cleared
ClearedEon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Diagnostics (Manufacturing) Ptyltd · KHS Enzymatic, Carbon-Dioxide
Cleared on Dec 15, 2010 after a 338-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 15, 2010
- Review
- 338 days
- Class
- Class II
- Product code
- KHS
- 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 KHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state…
Read the full statement (638 words)
The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data.
The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.
The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.
The Eon 100 is for in vitro diagnostic use only.
An amylase test system is a device intended to measure the quantitative activity of the enzyme amylase in serum and plasma on the EON 100 Chemistry Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
An albumin test system is a device intended to quantitatively measure the albumin concentration in serum and plasma on the EON 100 Chemistry Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
A bicarbonate/carbon dioxide test system is a device intended to quantitatively measure bicarbonate/carbon dioxide in serum and plasma on the EON 100 Chemistry Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Sodium
A sodium test system is a device intended to quantitatively measure sodium in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium
A potassium test system is a device intended to quantitatively measure potassium in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride
A chloride test system is a device intended to quantitatively measure the level of chloride in serum and plasma on the EON 100 Chemistry Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis
A Total protein test system is a device intended to quantitatively measure total protein(s) in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
A Uric acid test system is a device intended to quantitatively measure uric acid in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The Eon Calbrator Kit is a device intended for medical purposes for use in a test system to establish points of reference for albumin, total protein, and uric acid on the EON 100 Chemistry Analyzer that are used in the determination of values in the measurement of substances in human specimens.
The Eon Carbon Dioxide Calibrator is a device intended for medical purposes for use in the Eon Carbon Dioxide Reagent assay on the EON 100 Chemistry Analyzer to establish points of reference that are used in the determination of values in the measurement of carbon dioxide in serum and plasma.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100060: Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100060
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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