510(k) · Cleared
ClearedSynchron CX Systems Uric Acid (Uric) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · KNK Acid, Uric, Uricase (Colorimetric)
Cleared on May 21, 1997 as substantially equivalent to K881498 (Beckman Instruments, Inc., 1988) after a 70-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- May 21, 1997
- Review
- 70 days
- Class
- Class I
- Product code
- KNK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881498 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK881498 Synchron CX (TM)4 Clinical AnalyzerBeckman Instruments, Inc. · 1988 · Recalled
- This deviceK970919 Synchron CX Systems Uric Acid (Uric) ReagentBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881498 | Synchron CX (TM)4 Clinical Analyzer | Beckman Instruments, Inc. | 1988 | 1 |
| 0 (this device) | K970919 | Synchron CX Systems Uric Acid (Uric) Reagent | Beckman Instruments, Inc. | 1997 | — |
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 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? (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 |
|---|---|---|---|
| * | K881498 | Synchron CX (TM)4 Clinical AnalyzerSummary page 1…Acid test system. (21 CFR § 862.1775) 4.0 Predicate Device(s): ,,/") o« - 7/ Beckman SYNCHRON Beckman System Systems Instruments, Inc. . ; Beckman Dri-STAT® Unc K881498 Systems Uric Acid (URIC) Acid Trinder Reagent instruments, Inc Reagent as used on the SYNCHRON CX Systerns SYNCHRON LX Clinical S… | 1988 |
| * | — | Beckman SYNCHRON Systems Uric Acid (URIC) Reagent as used on the SYNCHRON CX Systems Named without a submission number |
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 a recall.
- 2 other devices also cite its predicate K881498.
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 | — |
What is it indicated for?
The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Calibrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
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/K970919 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970919: Synchron CX Systems Uric Acid (Uric) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970919
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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