510(k) · Cleared
ClearedCobas 8000 Ise Indirect NA, K, CI 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 21, 2013 as substantially equivalent to K963627 (Roche Diagnostic Systems, Inc., 1996) after a 168-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- May 21, 2013
- Review
- 168 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912649 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK912649 ISE/K+Boehringer Mannheim Corp. · 1991
- 1 generation backK963627 (Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc. · 1996
- This deviceK123726 Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics · 2013
- Descendant · cites it directly · 0 of its ownK140373 Ise Indirect NA, K, C1 for Gen 2Roche Diagnostics · 2014
Most influential descendants
Showing 1 of 1 · See all- K140373Ise Indirect NA, K, C1 for Gen 2Roche Diagnostics · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912649 | ISE/K+ | Boehringer Mannheim Corp. | 1991 | — |
| −1 | K963627 | (Modified Version) Integra Ion Selective Electrode (Ise) Module | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K123726 | Cobas 8000 Ise Indirect NA, K, CI for Gen. 2 | Roche Diagnostics | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K963627 | (Modified Version) Integra Ion Selective Electrode (Ise) ModuleSummary page 4…lyte imbalance. Substantial The following table compares the cobas 8000 1SF module and its predicate equivalence - device the CODAS INTEGRA ISF cleared under K963627. comparison Continued on next page… | 1996 |
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 |
|---|---|---|---|
| K140373 | Ise Indirect NA, K, C1 for Gen 2 | 2014 | 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 3 companies; a new generation was cleared every 16.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K140373 (Roche Diagnostics, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K963627.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 1SF 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/K123726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123726: Cobas 8000 Ise Indirect NA, K, CI for Gen. 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123726
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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