510(k) · Cleared
Recalled · Class II · 2025Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CDN Urease, Photometric, Urea Nitrogen
Cleared on Jul 20, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 20, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- CDN
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK001885 Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK023876 Vitros Chemistry Products MG Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK072440 Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K023876Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1Ortho-Clinical Diagnostics, Inc. · 2002 · cites it directly2descendants
- K072440Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…Ortho-Clinical Diagnostics, Inc. · 2007 · 2 generations on1descendant
- K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 3 generations on0descendants
- K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products… | Ortho-Clinical Diagnostics, Inc. | 2000 | — |
| +1 | K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1 | Ortho-Clinical Diagnostics, Inc. | 2002 | 1 |
| +2 | K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| +3 | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
| +1 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 2 | 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 CDN? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2025 | Class II | Z-1837-2025 | Storage | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test… |
| Jun 12, 2013 | Class II | Z-0301-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023876 (Ortho-Clinical Diagnostics, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CDN devicesCDN Urease, Photometric, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · CDN
Too few CDN 510(k)s in any year since 2007 to give a median.
Recalls per year · CDN
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDN
2in 2015
MAUDE reports naming product code CDN, 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 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001885: Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001885
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026