510(k) · Cleared
ClearedLithium Regent Model TR66056 / Lithium Standard TR66901
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trace America, Inc. · NDW Assay, Porphyrin, Spectrophotometry, Lithium
Cleared on Jan 17, 2001 after a 58-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 17, 2001
- Review
- 58 days
- Class
- Class II
- Product code
- NDW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK003583 Lithium Regent Model TR66056 / Lithium Standard TR66901Trace America, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK063705 Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2…Thermo Electron OY · 2007
- Descendant · cites it directly · 0 of its ownK070987 Sentinel Lithium AssaySENTINEL CH. SpA · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK033360 Diazyme Lithium Enzymatic Assay KitGeneral Atomics · 2003
Most influential descendants
Showing 3 of 3 · See all- K063705Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM…Thermo Electron OY · 2007 · cites it directly0descendants
- K070987Sentinel Lithium AssaySENTINEL CH. SpA · 2007 · cites it directly0descendants
- K033360Diazyme Lithium Enzymatic Assay KitGeneral Atomics · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901 | Trace America, Inc. | 2001 | — |
| +1 | K063705 | Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM… | Thermo Electron OY | 2007 | — |
| +1 | K070987 | Sentinel Lithium Assay | SENTINEL CH. SpA | 2007 | 2 |
| +1 | K033360 | Diazyme Lithium Enzymatic Assay Kit | General Atomics | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K063705 (Thermo Electron OY, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDW devicesNDW Assay, Porphyrin, Spectrophotometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K003583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003583
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026