510(k) · Cleared
ClearedCareside Bun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exigent Diagnostics, Inc. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Feb 5, 1998 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 30-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Feb 5, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- CDQ
- 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 deviceK980057 Careside BunExigent Diagnostics, Inc. · 1998
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) | K980057 | Careside Bun | Exigent Diagnostics, Inc. | 1998 | — |
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 CDQ? 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 CDQ device
- #1 K203771 Urea Nitrogen2score 3.7 · 2 generations · no Class I recall
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 Vitros BUN Slides (formerly Rastman Kodak, Inc.) and Johnson and Johnson's Vitros DT 60 (formerly Easunan Kodak's DT 60 II). Predicate Device S10K number: K912844/A Product Codc: 7SCDN (urease, urea) FROM @ EXIGENT DIARGNOSTICS INC. PHONE NO. : 3183386789 Jan. 29 1998 12:26… | 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 CDQ devicesCDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · CDQ
Too few CDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CDQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDQ
6in 2025
MAUDE reports naming product code CDQ, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 1 | 37 |
| 2012 | 0 | — | 0 | 44 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 231 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure BUN in whole blood, plasma-or serum specimens by professionals to aid in the diagnosis and treatment of various renal and metabolic diseases.
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/K980057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980057: Careside Bun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980057
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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