510(k) · Cleared
ClearedProlyte Electrolyte Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on May 7, 2008 as substantially equivalent to K823480 (Instrumentation Laboratory CO, 1983) and 3 other predicates after a 483-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- May 7, 2008
- Review
- 483 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K861087 (1986). 7 ancestors in all, the oldest K810615 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 1 generation backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- This deviceK070104 Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK102959 Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102959Prolyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −1 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| 0 (this device) | K070104 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2008 | — |
| +1 | K102959 | Prolyte Electrolyte Analyzer | Diamond Diagnostics, Inc. | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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? (4)
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 |
|---|---|---|---|
| * | K823480 | IL 943 Flame PhotometerSummary page 1…oride Test System 862.1170 Class II CGZ (6) Predicate Devices: Description 510(k) Analytes IL 943 Flame Photometer K823480 Sodium, Potassium EasyLyte K000926 Sodium, Potassium, Chloride AVL 9180… | 1983 |
| * | K000926 | Easyelectrolyte Analyzer and Rapidlyte AnalyzerSummary page 1…Predicate Devices: Description 510(k) Analytes IL 943 Flame Photometer K823480 Sodium, Potassium EasyLyte K000926 Sodium, Potassium, Chloride AVL 9180 K961458 Sodium, Potassium, Chloride 925 Chloridomete… | 2000 |
| * | K961458 | Avl 9180 Electrolyte AnalyzerSummary page 1…IL 943 Flame Photometer K823480 Sodium, Potassium EasyLyte K000926 Sodium, Potassium, Chloride AVL 9180 K961458 Sodium, Potassium, Chloride 925 Chloridometer K810615 Chloride Statement of Technology Characteri… | 1996 |
| * | K810615 | Corning 925 Chloride MeterSummary page 1…K000926 Sodium, Potassium, Chloride AVL 9180 K961458 Sodium, Potassium, Chloride 925 Chloridometer K810615 Chloride Statement of Technology Characteristics of the Device Compared to Predicate Device: Operating Principle… | 1981 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102959 | Prolyte Electrolyte Analyzer | 2011 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K102959 (Diamond Diagnostics, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K823480.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 proLYTE Electrolyte Analyzer is designed for clinical laboratory use by laboratory professionals to assess the levels of Sodium, Potassium, and Chloride found in whole blood, serum, plasma, and urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
This analyzer is used by laboratory trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte imbalance. These locations routinely conform to CLIA regulations, and conduct daily quality control programs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070104: Prolyte Electrolyte Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070104
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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