510(k) · Cleared
ClearedCareside Lytes, Careside Anallyzer Model 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careside, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Mar 18, 1999 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 71-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 18, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
- This deviceK990036 Careside Lytes, Careside Anallyzer Model 1000Careside, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912844 | Kodak Ektachem Dtii System | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K990036 | Careside Lytes, Careside Anallyzer Model 1000 | Careside, Inc. | 1999 | — |
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? (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 |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 1…number Product Code Vitros Na* DT SHAES c.c.vveeeeeeeeeeeeeeeeeereeenaene KO12844........cooeeeveeeinanns 75JGS/75CHH Vitros KX DT SHAES ...coveeeeeeeeeeeeeeeneeeneneene K912844.........ooovrverieannnen. 75CEM/75CHH Vitros CI' DT SHdes.......ooovreeeeiieeceeeeeienee, K912844.........ooeveveeeene. 75CGZ/75C… | 1991 |
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?
- Its one ancestor has no recall.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
CARESIDE LYTES™ For in vitro diagnostic use with the CARESIDE Analyzer™ to measure sodium, potassium and chloride ion concentrations using anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with electrolyte imbalance.
CARESIDE Analyzer™ For in vitro diagnostic use by laboratory professionals. Used in conjunction with reagent cartridges to duplicate manual analytical procedures in order to measure a variety of analytes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990036: Careside Lytes, Careside Anallyzer Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990036
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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