510(k) · Cleared
Recalled · Class II · 2015Uric Acid Pap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · KNK Acid, Uric, Uricase (Colorimetric)
Cleared on Oct 19, 1987 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 19, 1987
- Review
- 59 days
- Class
- Class I
- Product code
- KNK
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK873363 Uric Acid PapBoehringer Mannheim Corp. · 1987
- Descendant · cites it directly · 1 of its ownK981766 Uric AcidAbbott Laboratories · 1998
- Descendant · 2 generations on · 0 of its ownK102568 Uric Acid Model 3P39Abbott Laboratories · 2011
- Descendant · cites it directly · 0 of its ownK981189 Uric AcidAbbott Laboratories · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873363 | Uric Acid Pap | Boehringer Mannheim Corp. | 1987 | — |
| +1 | K981766 | Uric Acid | Abbott Laboratories | 1998 | — |
| +2 | K102568 | Uric Acid Model 3P39 | Abbott Laboratories | 2011 | — |
| +1 | K981189 | Uric Acid | Abbott Laboratories | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2011 | 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 KNK? 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? (3)
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 |
|---|---|---|---|---|
| May 7, 2015 | Class II | Z-1931-2015 | Under Investigation by firm | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981766 (Abbott Laboratories, 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNK devicesKNK Acid, Uric, Uricase (Colorimetric): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNK
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KNK
Too few KNK 510(k)s in any year since 2007 to give a median.
Recalls per year · KNK
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNK
2in 2025
MAUDE reports naming product code KNK, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 2 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 2 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K873363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K873363: Uric Acid Pap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873363
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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