510(k) · Cleared
ClearedK-ASSAY CRP (Ver.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamiya Biomedical Company, LLC · DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cleared on Apr 18, 2025 as substantially equivalent to K023828 (Kamiya Biomedical Co., 2003) after a 268-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Apr 18, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- DCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023828 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023828 K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D…Kamiya Biomedical Co. · 2003 · Recalled
- This deviceK242170 K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP… | Kamiya Biomedical Co. | 2003 | 1 |
| 0 (this device) | K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | 2025 | — |
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 DCK? 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 DCK device
- #1 K201256 Procise CRP, ProciseDx Analyzer, ProciseDx…score 4.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…Summary page 5…Regulatory Class: Class 2 Review Panel: Immunology Product Code: DCK 3. Predicate Device Trade Name: K-ASSAY ® CRP (3) 510(k) Number: K023828 4. Device Description The K-ASSAY ® CRP (Ver.2) assay quantifies C-reactive protein based on immunoturbidimetric… | 2003 |
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 K023828.
How does its category compare?
All DCK devicesDCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DCK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DCK
Too few DCK 510(k)s in any year since 2007 to give a median.
Recalls per year · DCK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCK
1in 2021
MAUDE reports naming product code DCK, 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 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
K-ASSAY CRP (Ver.2) is intended to be used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma (potassium-EDTA or lithium-heparin) by immunoturbidimetric assay. Measurement of CRP aids in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FOR IN VITRO DIAGNOSTIC USE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242170: K-ASSAY CRP (Ver.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242170
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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