510(k) · Cleared
ClearedModification to: Instaread Lithium System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akers Biosciences, Inc. · JIH Flame Photometry, Lithium
Cleared on Mar 4, 2005 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 4, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- JIH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIH? 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JIH devicesJIH Flame Photometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIH
FDA has decided no JIH device since 2007.
Median 510(k) review, days · JIH
Too few JIH 510(k)s in any year since 2007 to give a median.
Recalls per year · JIH
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIH
5in 2025
MAUDE reports naming product code JIH, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The InstaReadTM Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050338: Modification to: Instaread Lithium System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050338
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026