510(k) · Cleared
ClearedCobas Lithium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NDW Assay, Porphyrin, Spectrophotometry, Lithium
Cleared on Mar 21, 2008 as substantially equivalent to K963627 (Roche Diagnostic Systems, Inc., 1996) after a 465-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Mar 21, 2008
- Review
- 465 days
- Class
- Class II
- Product code
- NDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912649 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
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) | K063684 | Cobas Lithium | Roche Diagnostics Corp. | 2008 | — |
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 NDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 1…plasma on Roche/Hitachi cobas c systems. Predicate We claim substantial equivalence to the COBAS INTEGRA ISE Direct Device cleared as K963627 Substantial The table below indicates the similarities between the modified Lithium test equivalency - and its predicat… | 1996 |
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 17 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K963627.
How does its category compare?
All NDW devicesNDW Assay, Porphyrin, Spectrophotometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NDW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDW
Too few NDW 510(k)s in any year since 2007 to give a median.
Recalls per year · NDW
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDW
2in 2025
MAUDE reports naming product code NDW, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063684: Cobas Lithium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063684
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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