510(k) · Cleared
ClearedBun Reagent for Beckman Synchron CX & CX Delta Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · CDS Electrode, Ion Specific, Urea Nitrogen
Cleared on Jan 30, 2004 as substantially equivalent to K942676 (Beckman-Diagnostic Systems Group, 1994) and 1 other predicate after a 123-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jan 30, 2004
- Review
- 123 days
- Class
- Class II
- Product code
- CDS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864236 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864236 Synchron CX3Beckman Instruments, Inc. · 1986
- This deviceK033056 Bun Reagent for Beckman Synchron CX & CX Delta ReagentDiamond Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864236 | Synchron CX3 | Beckman Instruments, Inc. | 1986 | — |
| 0 (this device) | K033056 | Bun Reagent for Beckman Synchron CX & CX Delta Reagent | Diamond Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
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 CDS? 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? (2)
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 |
|---|---|---|---|
| * | K942676 | Synchron CX3 DeltaSummary page 1…BK-443350D BUN Reagent 443350 BUN Reagent * The predicate reagent, Beckman PN 443350, is encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively. 4. Device Description: Urea nitrogen concentrat… | 1994 |
| * | K864236 | Synchron CX3Summary page 1…BUN Reagent 443350 BUN Reagent * The predicate reagent, Beckman PN 443350, is encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively. 4. Device Description: Urea nitrogen concentration is determined by an e… | 1986 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K942676.
How does its category compare?
All CDS devicesCDS Electrode, Ion Specific, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDS
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CDS
Too few CDS 510(k)s in any year since 2007 to give a median.
Recalls per year · CDS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDS
1in 2022
MAUDE reports naming product code CDS, 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 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of blood urea nitrogen (BUN) in serum, plasma, and urine on Beckman Synchron CX® & CX® Delta Analyzers.
BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033056: Bun Reagent for Beckman Synchron CX & CX Delta Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033056
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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