510(k) · Cleared
ClearedParos CRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba, Ltd. · DCN System, Test, C-Reactive Protein
Cleared on Dec 23, 2002 as substantially equivalent to K002646 (Abx Diagnostics, 2000) and 1 other predicate after a 132-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Dec 23, 2002
- Review
- 132 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K860894 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- 2 generations backK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
- 1 generation backK981638 Immage Immunochemistry System C-Reactive Protein (CRP) ReagentBeckman Coulter, Inc. · 1998 · Recalled
- This deviceK022690 Paros CRPHoriba, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| −2 | K962523 | N Latex CRP Mono Reagent | Behring Diagnostics, Inc. | 1996 | — |
| −1 | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) Reagent | Beckman Coulter, Inc. | 1998 | 1 |
| 0 (this device) | K022690 | Paros CRP | Horiba, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 DCN? 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 DCN device
- #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K002646 | Abx Micros CRPSummary page 1…Whole Blood and Serum samples in-vitro. It employs the same measurement principles as the CRP measurement module of the ABX / Honba T’M~~ROS CRP (K002646, October 2000). The Paros CRF’ does not have a cell counting module. The CRP levels are measured in patients by reacting a… | 2000 |
| * | K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) ReagentSummary page 1…y equivalent to the following devices: 0 ABX / Honba TM MICROSCRP (KO02646 October 2000) 0 Beckman Coulter Immage IMMUNOCHEMISTRY S’YSTEM (K98 1638 June 1998). Description: The Paros CRP is a benchtop C-Reactive Protein Immunological Test System. It is a si… | 1998 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K002646.
How does its category compare?
All DCN devicesDCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DCN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DCN
234in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCN
7in 2025
MAUDE reports naming product code DCN, 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 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 3 | 111 | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 234 | 0 | 2 |
| 2019 | 0 | — | 1 | 8 |
| 2020 | 1 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The indications for use of the Paros CRP are for aiding in diagnosis and monitoring of inflammatory diseases. The primary utility is for screening for the presence of inflammatory disease, by measuring CRP on anti-coagulated whole blood samples, and thus eliminating the requirement for sample centrifugation. CRP measurement on serum samples is also possible.
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein, aids in evaluation of the amount of inflammatory injury to body tissues.
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/K022690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022690: Paros CRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022690
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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