510(k) · Cleared
ClearedCareside MG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careside, Inc. · JGJ Photometric Method, Magnesium
Cleared on Aug 10, 1999 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after an 82-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 10, 1999
- Review
- 82 days
- Class
- Class I
- Product code
- JGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
- This deviceK991717 Careside MGCareside, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912844 | Kodak Ektachem Dtii System | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K991717 | Careside MG | Careside, Inc. | 1999 | — |
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 JGJ? 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 |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 1…d Johnson’s (formerly Eastman Kodak, Inc.) Vitros Mg DT Slides for use on the Vitros DT 60 11 system (formerly Eastman Kodak’s DT 60 IT). Predicate Device 510K number: K912844/A Product Code: 75)JGJ] CARESIDE, Inc. CARESIDE™ Mg Premarket Notification Page 11 IV. May 19 1999 Device Des… | 1991 |
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?
- Its one ancestor has no recall.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All JGJ devicesJGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGJ
2in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JGJ
Too few JGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JGJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGJ
22in 2025
MAUDE reports naming product code JGJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 1 | 22 |
| 2013 | 0 | — | 1 | 26 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 1 | 24 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 0 | — | 1 | 31 |
| 2020 | 0 | — | 2 | 34 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 1 | 42 |
| 2023 | 0 | — | 0 | 31 |
| 2024 | 0 | — | 1 | 17 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure magnesium from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with hypomagnesemia or hypermagnesmia. It is intended professional laboratory use: not for point of care or physician office laboratory use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991717: Careside MG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991717
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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