510(k) · Cleared
ClearedSmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Oct 1, 2020 as substantially equivalent to K082462 (Diamond Diagnostics, Inc., 2009) after a 212-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Oct 1, 2020
- Review
- 212 days
- Class
- Class II
- Product code
- CEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K861087 (1986). 8 ancestors in all, the oldest K810615 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 2 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 1 generation backK082462 Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc. · 2009
- This deviceK200544 SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −2 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −1 | K082462 | Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ | Diamond Diagnostics, Inc. | 2009 | — |
| 0 (this device) | K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082462 | Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+Summary page 5…Class II JIH (6) Predicate Devices: Description 510(k) Measurand SmartLyte® (GEMLYTE) K082462 Sodium, Potassium, Chloride, Calcium and Lithium Statement of Technology Characteristics of the Device Compared to Predicate… | 2009 |
| † | K961458 | Avl 9180 Electrolyte Analyzer | 1996 |
| † | K823480 | IL 943 Flame Photometer | 1983 |
| † | K810615 | Corning 925 Chloride Meter | 1981 |
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.
What does this lineage say?
- The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K082462.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples. The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on…
Read the full statement (350 words)
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance 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.
The SmartLyte® Plus Potassium Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte 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.
The SmartLyte® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Calcium 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).
The SmartLyte® Plus Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200544: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200544
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026