510(k) · Cleared
ClearedUrea Nitrogen (Bun)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tech-Neal Scientific, Inc. · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Feb 11, 1988 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Feb 11, 1988
- Review
- 31 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK880078 Urea Nitrogen (Bun)Tech-Neal Scientific, Inc. · 1988
- Descendant · cites it directly · 0 of its ownK061879 Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry…Hemodiagnostica, LLC · 2006
Most influential descendants
Showing 1 of 1 · See all- K061879Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry SystemHemodiagnostica, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880078 | Urea Nitrogen (Bun) | Tech-Neal Scientific, Inc. | 1988 | — |
| +1 | K061879 | Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System | Hemodiagnostica, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061879 | Sdi CA480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System | 2006 | 0 |
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, K061879 (Hemodiagnostica, LLC, 2006) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K880078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880078: Urea Nitrogen (Bun).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880078
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026