510(k) · Cleared
ClearedCardioPhase® hsCRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostic Products GmbH · DCN System, Test, C-Reactive Protein
Cleared on Nov 27, 2023 as substantially equivalent to K221119 (Siemens Healthcare Diagnostics, Inc., 2023) after a 90-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 27, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- DCN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003419 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K221119 RCRP Flex reagent cartridgescore 6.0 · 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 |
|---|---|---|---|
| * | K221119 | RCRP Flex reagent cartridgeSummary page 4…gulatory Class: Class II 510(k) Review Panel Immunology (82) 3. Predicate Device Name of Device / 510(k): RCRP Flex® reagent cartridge / K221119 Regulation Number: 21 CFR 866.5270 Regulation Description: C-reactive protein immunological test system Product Co… | 2023 |
| † | K964527 | N Rheumatology Standard SL | 1997 |
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 22 years and passes through 3 companies; a new generation was cleared every 22.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
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. 2023, this device’s year, is highlighted.
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?
CardioPhase hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C‑reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury…
Read the full statement (135 words)
CardioPhase hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C‑reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232624: CardioPhase® hsCRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232624
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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