510(k) · Cleared
ClearedIse Indirect NA, K, C1 for Gen 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JGS Electrode, Ion Specific, Sodium
Cleared on May 22, 2014 as substantially equivalent to K123726 (Roche Diagnostics, 2013) after a 97-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- May 22, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912649 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK912649 ISE/K+Boehringer Mannheim Corp. · 1991
- 2 generations backK963627 (Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc. · 1996
- 1 generation backK123726 Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics · 2013
- This deviceK140373 Ise Indirect NA, K, C1 for Gen 2Roche Diagnostics · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912649 | ISE/K+ | Boehringer Mannheim Corp. | 1991 | — |
| −2 | K963627 | (Modified Version) Integra Ion Selective Electrode (Ise) Module | Roche Diagnostic Systems, Inc. | 1996 | — |
| −1 | K123726 | Cobas 8000 Ise Indirect NA, K, CI for Gen. 2 | Roche Diagnostics | 2013 | — |
| 0 (this device) | K140373 | Ise Indirect NA, K, C1 for Gen 2 | Roche Diagnostics | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 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? (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 |
|---|---|---|---|
| * | K123726 | Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Summary page 3…1SF module and the 1SF Gen 2 reagents were previously cleared for serum and plasma sample types under K 100853 and urine sample type on K1 23726. This premarket notification seeks to obtain FDA review and clearance for the urine sample typ… | 2013 |
| † | K100853 | Cobas 8000 Modular Series Analyzer | 2010 |
| † | K132418 | Cobas C 501 Ise Indirect NA, K, CL for Gen. 2 | 2013 |
| † | K053165 | Ise Indirect NA, K, CL for Gen.2 | 2005 |
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 23 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 cobas 8000 ISE module is a fully automated ion-specific analyzer intended for the in vitro potentiometric determination of chloride, potassium, and sodium in serum, plasma, and urine using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140373: Ise Indirect NA, K, C1 for Gen 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140373
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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