510(k) · Cleared
Recalled · Class II · 2026RCRP Flex reagent cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DCN System, Test, C-Reactive Protein
Cleared on Mar 17, 2023 as substantially equivalent to K003419 (Dade Behring, Inc., 2001) after a 333-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 17, 2023
- Review
- 333 days
- Class
- Class II
- Product code
- DCN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003419 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003419 RCRP Flex Reagent CartridgeDade Behring, Inc. · 2001 · Recalled
- This deviceK221119 RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK232624 CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003419 | RCRP Flex Reagent Cartridge | Dade Behring, Inc. | 2001 | 1 |
| 0 (this device) | K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +1 | K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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
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 |
|---|---|---|---|
| * | K003419 | RCRP Flex Reagent CartridgeSummary page 4…Regulation Number: 21 CFR 866.5270 4. Predicate Device Information Predicate Device Name: RCRP Flex® reagent cartridge assay 510(k) Number: K003419 5. Intended Use / Indications For Use The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical c… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232624 | CardioPhase® hsCRP | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 17, 2026 | Class II | Z-3335-2026 | Under Investigation by firm | The potential for falsely elevated results. |
| Mar 11, 2025 | Class II | Z-1551-2025 | Software Design Change | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K232624 (Siemens Healthcare Diagnostic Products GmbH, 2023) has gone furthest, with 0 descendants of its own.
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?
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221119: RCRP Flex reagent cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221119
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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